Search / Trial NCT00002558

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

Launched by MEMORIAL SLOAN KETTERING CANCER CENTER · Jan 26, 2003

Trial Information

Current as of December 07, 2024

Completed

Keywords

Recurrent Malignant Testicular Germ Cell Tumor Recurrent Ovarian Germ Cell Tumor Extragonadal Germ Cell Tumor

ClinConnect Summary

OBJECTIVES:

* Determine the safety of paclitaxel and ifosfamide followed by carboplatin and etoposide with stem cell support in patients with unfavorable germ cell tumors with unfavorable prognostic factors and resistance to cisplatin.
* Determine the efficacy of this regimen as salvage therapy in these patients.
* Escalate the dose of carboplatin based on a target area under the concentration time curve and renal function, and determine the pharmacokinetics of carboplatin in selected patients.
* Determine the qualitative effects of paclitaxel and ifosfamide on hematopoietic progenitors in...

Gender

ALL

Eligibility 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.

Trial Officials

Gnanamba V. Kondagunta, MD

Study Chair

Memorial Sloan Kettering Cancer Center

About Memorial Sloan Kettering Cancer Center

Memorial Sloan Kettering Cancer Center (MSKCC) is a world-renowned institution dedicated to cancer treatment, research, and education. As a leading clinical trial sponsor, MSKCC focuses on advancing innovative cancer therapies through rigorous scientific investigation and collaboration. The center's multidisciplinary team of experts employs cutting-edge methodologies to design and conduct trials that aim to improve patient outcomes and enhance understanding of cancer biology. With a commitment to translating research findings into clinical practice, MSKCC plays a pivotal role in shaping the future of oncology care and ensuring that patients have access to the latest therapeutic advancements.

Locations

New York, New York, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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