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NCT00002931 · REGISTRY CONDITION SEARCH

Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Relapsed Germ Cell Cancer

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

Phase
PHASE2
Status at capture
COMPLETED
Registry last update
2017-02-23

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. PURPOSE: This phase II trial is studying how well giving combination chemotherapy together with bone marrow transplantation or peripheral stem cell transplantation works in treating patients with relapsed germ cell 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

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baseline

Baseline characteristics

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outcome · POSTED

Progression-free Survival

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outcome · POSTED

Toxic Effects

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outcome · POSTED

Overall Survival

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
DISEASE CHARACTERISTICS: * Evaluable germ cell cancer (measurable by radiographic study and/or serum tumor marker elevation) and not curable by standard salvage therapy OR viable cancer on resection of post-chemotherapy residual masses in either intermediate or high risk category * Bidimensionally measurable disease with measurements performed within 21 days of study entry * Tumor marker (alpha-fetoprotein, lactate dehydrogenase, beta-human chorionic gonadotropin) studies performed within 7 days prior to study entry PATIENT CHARACTERISTICS: Age: * 16 and over Performance status: * Karnofsky 70-100% Life expectancy: * Not specified Hematopoietic: * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 120,000/mm\^3 * Hemoglobin at least 10 g/dL Hepatic: * Bilirubin no greater than 1.6 mg/dL * SGOT and SGPT no greater than 2 times upper limit of normal (ULN) * No active hepatitis or cirrhosis Renal: * Creatinine clearance at least 70 mL/min Cardiovascular: * Ejection fraction (MUGA or echocardiogram) normal * No EKG evidence of active cardiac disease (arrhythmias, ischemia) which would contraindicate etoposide and paclitaxel study treatment Pulmonary: * PaO\_2 at least 70 mm Hg * FEV\_1 at least 2 L or 75% * No history of bleomycin associated or serious lung disease Neurologic: * No steroid or glucocorticoid treatment for patients with CNS metastatic disease; at least 1 month with stable post-radiotherapy neurological status and seizure free; if prior seizures, at least 1 month with therapeutic anticonvulsant levels prior to study * Prior peripheral neuropathy requires consultation with principal investigator Other: * No significant active medical illness precluding study or survival * Not HIV positive * No prior malignancy within past 5 years except for adequately treated basal cell or squamous cell skin cancer * No prior hematologic malignancies PRIOR CONCURRENT THERAPY: Biologic therapy: * No prior bone marrow or stem cell rescue with high-dose chemotherapy Chemotherapy: * Prior chemotherapy allowed, excluding high-dose therapy with bone marrow or stem cell rescue * No prior paclitaxel Endocrine therapy: * Not specified Radiotherapy: * No concurrent radiotherapy during study Surgery: * Recovered from prior surgery
healthy Volunteers
false
maximum Age
120 Years
minimum Age
16 Years
sex
ALL
std Ages
  1. CHILD
  2. ADULT
  3. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. intervention Names
    1. Biological: filgrastim
    2. Drug: carboplatin
    3. Drug: etoposide
    4. Drug: ifosfamide
    5. Drug: paclitaxel
    6. Procedure: autologous bone marrow transplantation
    7. Procedure: bone marrow ablation with stem cell support
    label
    HD Chemo and Auto Stem Cells
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. HD Chemo and Auto Stem Cells
    description
    5 ug/kg bid beginning 4 days prior to and continuing through stem cell collection.
    name
    filgrastim
    type
    BIOLOGICAL
  2. arm Group Labels
    1. HD Chemo and Auto Stem Cells
    description
    AUC=7, daily X 3
    name
    carboplatin
    type
    DRUG
  3. arm Group Labels
    1. HD Chemo and Auto Stem Cells
    description
    20 mg/kg by 2 hours infusion daily X 3
    name
    etoposide
    type
    DRUG
  4. arm Group Labels
    1. HD Chemo and Auto Stem Cells
    description
    3 gm/m2 IV over 30 minutes X 3 days
    name
    ifosfamide
    type
    DRUG
  5. arm Group Labels
    1. HD Chemo and Auto Stem Cells
    description
    425 mg/m2 as 24 hour continuous infusion
    name
    paclitaxel
    type
    DRUG
  6. arm Group Labels
    1. HD Chemo and Auto Stem Cells
    description
    Given in two divided infusions on day -2 and day 0
    name
    autologous bone marrow transplantation
    type
    PROCEDURE
  7. arm Group Labels
    1. HD Chemo and Auto Stem Cells
    description
    Two cycles of high dose chemotherapy followed by stem cell reinfusion
    name
    bone marrow ablation with stem cell support
    type
    PROCEDURE
Study design
allocation
NA
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
48
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    Estimated using the product-limit method of Kaplan and Meier. Progression is defined as an increase o any radiologically measureable tumor by greater than 25% or a greater than 10% increase of elevated tumor markers.
    measure
    Progression-free Survival
    time Frame
    Until disease progression, up to 5 years.
  2. description
    Number of Participants with Grade 3 and 4 Adverse Events Related to Protocol-based Therapy
    measure
    Toxic Effects
    time Frame
    From date of randomization until death of any cause, assessed up to 12 weeks
secondary Outcomes
  1. description
    Estimated using the product-limit method of Kaplan and Meier.
    measure
    Overall Survival
    time Frame
    Until death from any cause, up to 5 years.
Full study description
brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. PURPOSE: This phase II trial is studying how well giving combination chemotherapy together with bone marrow transplantation or peripheral stem cell transplantation works in treating patients with relapsed germ cell cancer.
detailed Description
OBJECTIVES: * Estimate the antitumor activity of 2 courses of paclitaxel and carboplatin regimens with autologous stem cell rescue in patients with relapsed germ cell cancer. * Evaluate the toxic effects of paclitaxel, carboplatin and etoposide (VP-16) with stem cell support followed by paclitaxel, carboplatin and ifosfamide with stem cell support in these patients. OUTLINE: Patients receive filgrastim (G-CSF) SC or IV 4 days prior to peripheral blood stem cells (PBSC) apheresis. Autologous bone marrow harvest is performed when adequate stem cells cannot be collected. Patients then receive course 1 of high-dose chemotherapy beginning on day -7 with paclitaxel IV over 24 hours. On days -6 to -4, patients receive etoposide IV over 2 hours and carboplatin (CBDCA) IV over 30 minutes 3 times daily. Following a 2 or 3 week recovery, a second course of chemotherapy begins on day -7, consisting of paclitaxel IV over 24 hours, then CBDCA and ifosfamide on days -6 to -4. Reinfusion of PBSC and marrow begins on day -2 in both course 1 and 2. In addition, G-CSF IV is given twice a day until 3 consecutive postnadir days of granulocytes of at least 1000/mm\^3 are maintained. On day 0, stem cells with or without bone marrow product are again administered. Surgery may be performed after course 2 if indicated. PROJECTED ACCRUAL: The expected accrual rate is 12 patients per year over 2 years.
Source references
Source notices and limitations
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    Preserved source evidence · Not medical advice