Skip to content
Triangle logo TriangleGet started
← Study library

NCT00014495 · REGISTRY CONDITION SEARCH

Chemotherapy and Monoclonal Antibody Therapy in Treating Patients With Advanced Myeloid Cancer

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE1, PHASE2
Status at capture
COMPLETED
Registry last update
2016-01-22

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining monoclonal antibody therapy with chemotherapy may kill more cancer cells. PURPOSE: Phase I/II trial to study the effectiveness of combining chemotherapy and monoclonal antibody therapy in treating patients who have advanced myeloid cancer.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

→

baseline

Baseline characteristics

→

outcome · POSTED

Maximum Tolerated Dose

→

adverse events

Adverse events

→

more info

Limitations, agreements, and source contact

→
Who could take part
eligibility Criteria
DISEASE CHARACTERISTICS: * One of the following diagnoses: * Pathologically confirmed acute myeloid leukemia (AML) meeting one of the following criteria: * Newly diagnosed AML, over age 60, and not eligible for higher priority protocols * Newly diagnosed AML and unable to receive anthracycline-containing or high-dose cytarabine-containing regimens * AML in relapse * AML refractory to two courses of standard induction chemotherapy or one course of high-dose cytarabine-containing induction chemotherapy * Chronic myelogenous leukemia in accelerated phase or myeloid blast crisis * Refractory anemia with excess blasts (RAEB), RAEB in transformation, or chronic myelomonocytic leukemia * More than 25% of bone marrow blasts must be CD33 positive * Not a candidate for immediate bone marrow transplantation with a HLA-compatible donor * No active CNS leukemia PATIENT CHARACTERISTICS: Age: * Not specified Performance status: * Karnofsky 60-100% Life expectancy: * Not specified Hematopoietic: * Not specified Hepatic: * Bilirubin no greater than 2 mg/dL (unless due to leukemia or Gilbert's disease) * Alkaline phosphatase no greater than 2.5 times upper limit of normal (ULN) * AST no greater than 2.5 times ULN Renal: * Creatinine less than 2 mg/dL OR * Creatinine clearance greater than 60 mL/min Cardiovascular: * No New York Heart Association class III or IV cardiac disease Pulmonary: * No pulmonary disease Other: * No detectable antibodies to monoclonal antibody M195 * No serious active uncontrolled infection * No other concurrent active malignancy requiring therapy * No other serious or life-threatening conditions that would preclude study * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * At least 3 weeks since prior biologic therapy and recovered Chemotherapy: * See Disease Characteristics * Prior hydroxyurea allowed if discontinued before study treatment * At least 3 weeks since other prior chemotherapy and recovered Endocrine therapy: * Not specified Radiotherapy: * At least 3 weeks since prior radiotherapy and recovered Surgery: * Not specified
healthy Volunteers
false
maximum Age
120 Years
sex
ALL
std Ages
  1. CHILD
  2. ADULT
  3. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Patients receive cytarabine IV continuously on days 1-5. Beginning between days 7 and 14, patients receive Bi213 MOAB M195 IV over 5 minutes up to 4 times daily over 1-4 days. Patient also receive filgrastim (G-CSF) subcutaneously daily beginning 24 hours after the final Bi213 MOAB M195 infusion and continuing until blood counts recover. Treatment continues in the absence of disease progression or unacceptable toxicity. Cohorts of 3 to 6 patients receive escalating doses of Bi213 MOAB M195 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, subsequent patients are treated at the MTD. Patients are followed twice weekly for 4 weeks and then monthly for 3 months
    intervention Names
    1. Biological: filgrastim
    2. Drug: cytarabine
    3. Radiation: bismuth Bi213 monoclonal antibody M195
    label
    bismuth Bi 213 monoclonal antibody M195 & cytarabine
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. bismuth Bi 213 monoclonal antibody M195 & cytarabine
    name
    filgrastim
    type
    BIOLOGICAL
  2. arm Group Labels
    1. bismuth Bi 213 monoclonal antibody M195 & cytarabine
    name
    cytarabine
    type
    DRUG
  3. arm Group Labels
    1. bismuth Bi 213 monoclonal antibody M195 & cytarabine
    name
    bismuth Bi213 monoclonal antibody M195
    type
    RADIATION
Study design
allocation
NA
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
32
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    The maximum tolerated dose of bismuth Bi 213 monoclonal antibody M195 following cytarabine in patients with advanced myeloid malignancies.
    measure
    Maximum Tolerated Dose
    time Frame
    2 years
Full study description
brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining monoclonal antibody therapy with chemotherapy may kill more cancer cells. PURPOSE: Phase I/II trial to study the effectiveness of combining chemotherapy and monoclonal antibody therapy in treating patients who have advanced myeloid cancer.
detailed Description
OBJECTIVES: * Determine the maximum tolerated dose of bismuth Bi 213 monoclonal antibody M195 following cytarabine in patients with advanced myeloid malignancies. * Determine the antileukemic effects of this treatment in this patient population. * Determine the toxicity of this treatment in this patient population. * Determine the complete remission rate of patients treated with this treatment regimen. OUTLINE: This is a dose escalation study of bismuth Bi 213 monoclonal antibody M195 (Bi213 MOAB M195). Patients receive cytarabine IV continuously on days 1-5. Beginning between days 7 and 14, patients receive Bi213 MOAB M195 IV over 5 minutes up to 4 times daily over 1-4 days. Patient also receive filgrastim (G-CSF) subcutaneously daily beginning 24 hours after the final Bi213 MOAB M195 infusion and continuing until blood counts recover. Treatment continues in the absence of disease progression or unacceptable toxicity. Cohorts of 3 to 6 patients receive escalating doses of Bi213 MOAB M195 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, subsequent patients are treated at the MTD. Patients are followed twice weekly for 4 weeks and then monthly for 3 months.
Source references
references
  1. citation
    Rosenblat TL, McDevitt MR, Mulford DA, Pandit-Taskar N, Divgi CR, Panageas KS, Heaney ML, Chanel S, Morgenstern A, Sgouros G, Larson SM, Scheinberg DA, Jurcic JG. Sequential cytarabine and alpha-particle immunotherapy with bismuth-213-lintuzumab (HuM195) for acute myeloid leukemia. Clin Cancer Res. 2010 Nov 1;16(21):5303-11. doi: 10.1158/1078-0432.CCR-10-0382. Epub 2010 Sep 21.
    pmid
    20858843
    type
    RESULT
  2. citation
    Mulford DA, Pandit-Taskar N, McDevitt MR, et al.: Sequential therapy with cytarabine and bismuth-213 (213Bi)-labeled-HuM195 (Anti-CD33) for acute myeloid leukemia (AML). [Abstract] Blood 104 (11): A-1790, 2004.
    type
    RESULT
Source notices and limitations
    Discovery and provenance
    1. release id
      ctgov-registry-1336d216cbd1bbff780dac70
      edge id
      nct-edge-0c1476925a23de0df5e2
      requested nct id
      NCT00014495
      primary nct id
      NCT00014495
      source kind
      ctgov_condition_query
      source record id
      Source null
      source file sha256
      193739e64f77123de4344901c9970a0996a667fa587f14135380bef3ae38e11d
      payload sha256
      fca485dfaf841fa64ff62a92ff75ca3ad5cbdf1478dc18b412485d7923b9f5c7
      payload
      clinical indication matching status
      condition_index_match_asserted_by_registry_not_reviewed
      end exclusive
      true
      id
      nct-edge-0c1476925a23de0df5e2
      link basis
      returned_by_explicit_condition_and_posted_results_filter_query
      nct id
      NCT00014495
      occurrences
      1. context exact
        NCT00014495
        end
        11
        exact text
        NCT00014495
        start
        0
      offset unit
      unicode_code_points
      query cond
      Childhood Chronic Myeloid Leukemia
      query disease state id
      ds-chronic-myeloid-leukemia-pediatric
      source file
      /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-childhood-chronic-myeloid-leukemia-000.json
      source file sha256
      193739e64f77123de4344901c9970a0996a667fa587f14135380bef3ae38e11d
      source json pointer
      /studies/16/protocolSection/identificationModule/nctId
      source kind
      ctgov_condition_query
      source record id
      Source null
      source string basis
      parsed_JSON_string_unmodified
      source string sha256
      1d3d57a4c5eb74a9e5c5de991198a526d08577abd60c05a02704a3e23c83210c
    2. release id
      ctgov-registry-1336d216cbd1bbff780dac70
      edge id
      nct-edge-85d73099ae455d7bab5c
      requested nct id
      NCT00014495
      primary nct id
      NCT00014495
      source kind
      ctgov_condition_query
      source record id
      Source null
      source file sha256
      cddcd4e3a59550bc78924062a298c359d8f811413f73f4a4461963aecf3790d6
      payload sha256
      8aef54d90c7a37ad8461254a71643c8745693392b91930a09565eef3198be7c9
      payload
      clinical indication matching status
      condition_index_match_asserted_by_registry_not_reviewed
      end exclusive
      true
      id
      nct-edge-85d73099ae455d7bab5c
      link basis
      returned_by_explicit_condition_and_posted_results_filter_query
      nct id
      NCT00014495
      occurrences
      1. context exact
        NCT00014495
        end
        11
        exact text
        NCT00014495
        start
        0
      offset unit
      unicode_code_points
      query cond
      Juvenile Myelomonocytic Leukemia
      query disease state id
      ds-juvenile-myelomonocytic-leukemia
      source file
      /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-juvenile-myelomonocytic-leukemia-000.json
      source file sha256
      cddcd4e3a59550bc78924062a298c359d8f811413f73f4a4461963aecf3790d6
      source json pointer
      /studies/33/protocolSection/identificationModule/nctId
      source kind
      ctgov_condition_query
      source record id
      Source null
      source string basis
      parsed_JSON_string_unmodified
      source string sha256
      1d3d57a4c5eb74a9e5c5de991198a526d08577abd60c05a02704a3e23c83210c
    3. release id
      ctgov-registry-1336d216cbd1bbff780dac70
      edge id
      nct-edge-9c2da578c71ed5783654
      requested nct id
      NCT00014495
      primary nct id
      NCT00014495
      source kind
      ctgov_condition_query
      source record id
      Source null
      source file sha256
      a4be8fb2a7db9247bdfed231ef84ae19b3babbe8d619ebf7403cceb730eae2d4
      payload sha256
      3000c44fb11914e79b76ab93fe4edf499616cd0be823c396540a05622ef3aeb8
      payload
      clinical indication matching status
      condition_index_match_asserted_by_registry_not_reviewed
      end exclusive
      true
      id
      nct-edge-9c2da578c71ed5783654
      link basis
      returned_by_explicit_condition_and_posted_results_filter_query
      nct id
      NCT00014495
      occurrences
      1. context exact
        NCT00014495
        end
        11
        exact text
        NCT00014495
        start
        0
      offset unit
      unicode_code_points
      query cond
      Childhood Myelodysplastic Neoplasms
      query disease state id
      ds-myelodysplastic-neoplasms-pediatric
      source file
      /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-childhood-myelodysplastic-neoplasms-000.json
      source file sha256
      a4be8fb2a7db9247bdfed231ef84ae19b3babbe8d619ebf7403cceb730eae2d4
      source json pointer
      /studies/19/protocolSection/identificationModule/nctId
      source kind
      ctgov_condition_query
      source record id
      Source null
      source string basis
      parsed_JSON_string_unmodified
      source string sha256
      1d3d57a4c5eb74a9e5c5de991198a526d08577abd60c05a02704a3e23c83210c

    Preserved source evidence · Not medical advice