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

• Status: Completed
• Trial end date: 2009-04-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy, such as paclitaxel, ifosfamide, carboplatin, and etoposide work in different ways to stop the growth of tumor cells, either by killing them or by stopping them from dividing. Giving chemotherapy with a peripheral stem cell transplant may allow more chemotherapy to be given so that more tumor cells are killed.

The design of this trial is a phase I/II trial of sequential accelerated chemotherapy cycles with taxol/ifosfamide and carboplatin/etoposide administered with G-CSF and PBSC support.

PURPOSE: The purpose of this study is to determine the effects of an intensive sequence of chemotherapy drugs in patients with metastatic germ cell cancer. All of these chemotherapy drugs are known to be active in this disease.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Memorial Sloan Kettering Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Carboplatin; Etoposide; Etoposide phosphate; Ifosfamide; Isophosphamide mustard; Paclitaxel

Criteria

Inclusion criteria:

• Male/Female with histologically confirmed GCT with review by the Department of Pathology at this center.

• Patients with advanced GCT, including patients with:

measurable or evaluable disease,

• patients with only elevated serum tumor markers (AFP and/or HCG), or

• patients with known residual disease after postchemotherapy surgery. Eligible patients must have established clinical resistance to cisplatin by their failure to achieve a durable CR to a cisplatin-based regimen.

• Prior treatment limited to ≤ 6 prior cycles (≤ four cycles preferred) of cisplatin. (GROUP A)

• Prior therapy > 6 cycles of cisplatin. (GROUP B)

• Therapy must have been discontinued at least 3 weeks before entry onto protocol.

• Patients must have one or more unfavorable prognostic factors for achieving a CR to cisplatin-based salvage therapy. These are:

• Extragonadal primary site.

• Testis/ovarian primary site with the best response of an IR to first-line therapy, or a partial response with normal tumor markers of six months or less in duration.

• Prior treatment with ifosfamide-containing therapy

• General medical condition sufficient to allow for general anesthesia at the time of pheresis catheter placement.

• Patients must have negative serology for Human Immunodeficiency Virus.

• Laboratory criteria for protocol entry:

WBC ≥ 3000/ul Platelets 3 100,000/ul Cr Clearance > 50 cc/min*

• (unless renal dysfunction is due to tumor obstructing the ureters in which case eligibility will be determined by the Principal Investigator).

• Age ≥ 15 years.

• Signed informed consent.

Exclusion Criteria:

• Presence of active infection

• Concurrent treatment with chemotherapy or

• Inability to comply with the treatment protocol or to undergo the specified follow-up tests for safety or effectiveness.

• Prior high-dose therapy with AuBMT.

• Patients must have recovered from recent surgery.