NCT00936936 · REGISTRY CONDITION SEARCH

High-dose Chemotherapy for Poor-Prognosis Relapsed Germ-Cell Tumors

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: 2024-08-26

The goal of this clinical research study is to learn if 2 cycles of high-dose chemotherapy can help to control germ-cell tumors. The first cycle of chemotherapy will include the drugs gemcitabine, docetaxel, melphalan, and carboplatin. The second cycle of chemotherapy will include the drugs ifosfamide, carboplatin, and etoposide. The safety of these drug combinations will also be studied. This is an investigational study. Gemcitabine, docetaxel, melphalan, ifosfamide, carboplatin, and etoposide are all FDA-approved and commercially available for the treatment of germ-cell tumors. Up to 67 patients will be enrolled in this study.

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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

Number of Participants With 2-year Event-Free Survival (EFS)

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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: Inclusion Criteria: 1. Male or female patients, age 12 to 65 years. 2. Patients with seminomatous or nonseminomatous germ-cell tumors (GCT) in one of the following groups: A) First relapse or progression or second response with an intermediate or high risk according to the Beyer model. B) Second relapse or beyond. 3. Adequate renal glomerular and tubular function, as defined by estimated serum creatinine clearance \>/=50 ml/min and/or serum creatinine \</= 1.8 mg/dL, and urinary protein excretion \</=500 mg/day. 4. Adequate hepatic function, as defined by ALT and AST \</=3 x upper limit of normal (ULN); serum bilirubin and alkaline phosphatase \</=2 x ULN or considered not clinically significant. 5. Adequate pulmonary function with FEV1 (Forced expiratory volume in the first second), FVC (Forced vital capacity) and DLCO (diffusing capacity of the lung for carbon monoxide) \>/=50% of predicted, corrected for volume and hemoglobin. 6. Adequate cardiac function with LVEF (left ventricular ejection fraction) \>/=40%. No uncontrolled arrhythmias or symptomatic cardiac disease. 7. Zubrod performance status 0-2. 8. A minimum apheresis collection of 5 million CD34+ cells/kg of autologous hematopoietic progenitor cells (AHPC). 9. Written informed consent by patients and/ or their parents or legal guardians. Assent for those patients inclusive of ages 12 to 17. Exclusion Criteria: 1. Growing teratoma syndrome, defined as enlarging tumor masses with normal serum markers during chemotherapy for nonseminomatous GCT. 2. Major surgery within 30 days before the initiation of study treatment 3. Radiotherapy within 21 days prior to initiation of study treatment 4. Prior whole brain irradiation. 5. Patients with active central nervous system (CNS) disease, defined as brain or meningeal metastases that are not in complete remission. 6. Patients with active hepatitis B, either active carrier (HBsAg +) or viremic (HBV DNA \>/=10,000 copies/mL, or \>/= 2,000 IU/mL). 7. Evidence of either cirrhosis or stage 3-4 liver fibrosis in patients who either show chronic hepatitis C or positive hepatitis C serology. 8. Active infection requiring parenteral antibiotics. 9. HIV infection, unless the patient is receiving effective antiretroviral therapy with undetectable viral load and normal CD4 counts 10. Patients who have had a previous autologous or allogeneic stem cell transplant in the previous 12 months. 11. Positive pregnancy test in a female patient of childbearing potential defined as not post menopausal for twelve months or no previous surgical sterilization.
healthy Volunteers: false
maximum Age: 65 Years
minimum Age: 12 Years
sex: ALL
std Ages: CHILD
ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
First Cycle High-dose (HD) chemotherapy followed by stem-cell infusion (PBPC) HD Cycle #1: Gemcitabine/Docetaxel/Melphalan/Carboplatin + PBPC
intervention Names
Drug: Gemcitabine
Drug: Docetaxel
Drug: Melphalan
Drug: Carboplatin
Procedure: Stem Cell Transplant
label
Cycle # 1
type
EXPERIMENTAL
description
Second Cycle High-dose (HD) chemotherapy followed by stem-cell infusion (PBPC) HD Cycle #2: Ifosfamide/Carboplatin/Etoposide + PBPC
intervention Names
Drug: Carboplatin
Drug: Mesna
Drug: Ifosfamide
Drug: Etoposide
Procedure: Stem Cell Transplant
label
Cycle #2
type
EXPERIMENTAL

interventions

arm Group Labels
Cycle # 1
description
1800 mg/m\^2 IV over 3 hours on Days -5 to Day -2.
name
Gemcitabine
other Names
Gemcitabine Hydrochloride
Gemzar
type
DRUG
arm Group Labels
Cycle # 1
description
Docetaxel 300 mg/m\^2 IV over 2 hours on Day -5.
name
Docetaxel
other Names
Taxotere
type
DRUG
arm Group Labels
Cycle # 1
description
50 mg/m\^2 IV over 15 minutes on Days -4 to Day -2.
name
Melphalan
other Names
Alkeran
type
DRUG
arm Group Labels
Cycle # 1
Cycle #2
description
Cycle 1: 333 mg/m\^2 IV over 2 hours on Days -4 to -2. Cycle #2: 300 mg/m\^2 IV over 2 hours on Days -6 to -3.
name
Carboplatin
other Names
Paraplatin
type
DRUG
arm Group Labels
Cycle #2
description
3,000 mg/m\^2 per day in 96-hour continuous infusion, starting 30 minutes prior to the first dose of ifosfamide, on Days -6 to -4.
name
Mesna
other Names
Mesnex
type
DRUG
arm Group Labels
Cycle #2
description
3,000 mg/m\^2 IV over 6 hours on Days -6 to -3
name
Ifosfamide
other Names
Ifex
type
DRUG
arm Group Labels
Cycle #2
description
200 mg/m\^2 IV over 3 hours, every 12 hours on Days -6 to -4.
name
Etoposide
other Names
VePesid
type
DRUG
arm Group Labels
Cycle # 1
Cycle #2
description
Stem cell infusion on Day 0.
name
Stem Cell Transplant
other Names
SCT
Hematopoietic progenitor-cell infusion
PBPC
type
PROCEDURE

Study design

allocation

NON_RANDOMIZED

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 64
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
Event-free survival estimated from the first day of High-Dose Course Cycle #1 (Day -6) until tumor progression, relapse, or death from any cause.
measure
Number of Participants With 2-year Event-Free Survival (EFS)
time Frame
2 Years

secondary Outcomes

description
Number of Participants alive and disease free 1 year post treatment completion.
measure
Overall Survival
time Frame
1 year post treatment

Full study description

brief Summary: The goal of this clinical research study is to learn if 2 cycles of high-dose chemotherapy can help to control germ-cell tumors. The first cycle of chemotherapy will include the drugs gemcitabine, docetaxel, melphalan, and carboplatin. The second cycle of chemotherapy will include the drugs ifosfamide, carboplatin, and etoposide. The safety of these drug combinations will also be studied. This is an investigational study. Gemcitabine, docetaxel, melphalan, ifosfamide, carboplatin, and etoposide are all FDA-approved and commercially available for the treatment of germ-cell tumors. Up to 67 patients will be enrolled in this study.
detailed Description: The Study Drugs: Carboplatin, melphalan, and ifosfamide are designed to damage the DNA (the genetic material) of cancer cells, which may cause the cancer cells to die. Docetaxel and etoposide are designed to stop the growth of cancer cells, which may cause the cancer cells to die. Gemcitabine is designed to disrupt the growth of cancer cells, which may cause cancer cells to die. It may also help docetaxel, carboplatin, and melphalan to be more effective by stopping tumor cells from repairing damage caused by these drugs. Study Drug Administration: You will receive 2 cycles of high-dose chemotherapy with stem-cell support, 1-2 months apart. You will receive 1 dose of Outpatient IV at Bevacizumab 7.5mg/kg. Starting on the first day of your hospital stay, you will begin gargling and swishing Caphosol and Glutamine in your mouth 4 times a day. This is done to help prevent mouth and throat sores. On Day 2 of your stay in the hospital, through the CVC, you will receive gemcitabine over 4 hours and docetaxel over 2 hours. On Days 3-5, through the CVC, you will receive gemcitabine over 4 hours, melphalan over 15 minutes, and carboplatin over 2 hours. On Day 6, you will not receive any study drugs. On Day 7, you will receive the stem cells through the CVC over about 30-60 minutes. As part of standard care, you will receive G-CSF (filgrastim) as an injection under your skin daily, starting 5 days after the transplant, until your blood cell levels return to normal. As part of standard mouth care you will be asked to do mouthwashes 4 times a day with caphosol (artificial saliva) and glutamine. Two (2) to 4 weeks after you leave the hospital after Cycle 1, you will receive your second cycle of high-dose chemotherapy. On Days 2-4 of your stay in the hospital, through the CVC, you will receive ifosfamide over 6 hours, etoposide over 2 hours, and carboplatin over 2 hours. On Days 5-6, you will not receive any study drugs. On Day 7, you will receive the stem cells through the CVC over about 30-60 minutes. Study Visits: About 1 month, 100 days, 6 months and 1 year after your second stem cell transplant, the following tests and procedures will be performed: * To check the status of the disease, you will have CT scans of your chest, abdomen, and pelvis. * Blood (about 3 tablespoons) will be drawn for routine tests. Length of Study: You will be off study after about 1 year from your second transplant. You will be taken off study early if the disease gets worse or if you experience any intolerable side effects. Long-Term Follow-up: If your doctor thinks it is needed, you may have follow-up visits.

Source references

references

citation
Nieto Y, Tu SM, Bassett R, Jones RB, Gulbis AM, Tannir N, Kingham A, Ledesma C, Margolin K, Holmberg L, Champlin R, Pagliaro L. Bevacizumab/high-dose chemotherapy with autologous stem-cell transplant for poor-risk relapsed or refractory germ-cell tumors. Ann Oncol. 2015 Oct;26(10):2125-32. doi: 10.1093/annonc/mdv310. Epub 2015 Jul 21.
pmid
26199392
type
DERIVED