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

February 5, 2024 updated by: M.D. Anderson Cancer Center

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

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.

Study Type

Interventional

Enrollment (Actual)

64

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77007
        • University of Texas MD Anderson Cancer Center
    • Washington
      • Seattle, Washington, United States, 98109
        • Fred Hutchinson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cycle # 1

First Cycle High-dose (HD) chemotherapy followed by stem-cell infusion (PBPC)

HD Cycle #1: Gemcitabine/Docetaxel/Melphalan/Carboplatin + PBPC
Drug: Gemcitabine
1800 mg/m^2 IV over 3 hours on Days -5 to Day -2.
Other Names:
  • Gemzar
  • Gemcitabine Hydrochloride
Drug: Docetaxel
Docetaxel 300 mg/m^2 IV over 2 hours on Day -5.
Other Names:
  • Taxotere
Drug: Melphalan
50 mg/m^2 IV over 15 minutes on Days -4 to Day -2.
Other Names:
  • Alkeran
Drug: Carboplatin

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.

Other Names:
  • Paraplatin
Procedure: Stem Cell Transplant
Stem cell infusion on Day 0.
Other Names:
  • SCT
  • Hematopoietic progenitor-cell infusion
  • PBPC
Experimental: Cycle #2

Second Cycle High-dose (HD) chemotherapy followed by stem-cell infusion (PBPC)

HD Cycle #2: Ifosfamide/Carboplatin/Etoposide + PBPC
Drug: Carboplatin

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.

Other Names:
  • Paraplatin
Procedure: Stem Cell Transplant
Stem cell infusion on Day 0.
Other Names:
  • SCT
  • Hematopoietic progenitor-cell infusion
  • PBPC
Drug: Mesna
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.
Other Names:
  • Mesnex
Drug: Ifosfamide
3,000 mg/m^2 IV over 6 hours on Days -6 to -3
Other Names:
  • Ifex
Drug: Etoposide
200 mg/m^2 IV over 3 hours, every 12 hours on Days -6 to -4.
Other Names:
  • VePesid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
2-year Event-Free Survival (EFS)
Time Frame: 2 Years
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.
2 Years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Investigators

  • Study Chair: Yago Nieto, MD, PHD, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 2, 2009

Primary Completion (Actual)

January 11, 2024

Study Completion (Actual)

January 11, 2024

Study Registration Dates

First Submitted

July 8, 2009

First Submitted That Met QC Criteria

July 9, 2009

First Posted (Estimated)

July 10, 2009

Study Record Updates

Last Update Posted (Actual)

February 6, 2024

Last Update Submitted That Met QC Criteria

February 5, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2008-0378
  • NCI-2011-01631 (Registry Identifier: NCI CTRP)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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