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Phase I/II Trial of Sequential Paclitaxel/Ifosfamide Followed by Dose-Escalated, Dose-Intensive Carboplatin, Paclitaxel and Ifosfamide With Stem Cell Support in Cisplatin-Resistant Germ Cell Tumor Patients


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Brain and Central Nervous System Tumors, Extragonadal Germ Cell Tumor, Ovarian Cancer, Teratoma, Testicular Germ Cell Tumor

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Trial Information

Phase I/II Trial of Sequential Paclitaxel/Ifosfamide Followed by Dose-Escalated, Dose-Intensive Carboplatin, Paclitaxel and Ifosfamide With Stem Cell Support in Cisplatin-Resistant Germ Cell Tumor Patients


OBJECTIVES:

- Determine the safety of paclitaxel and ifosfamide followed by dose-escalated,
dose-intensive paclitaxel, carboplatin, and ifosfamide with autologous peripheral blood
stem cell support in patients with cisplatin-resistant germ cell tumor. (Phase I)

- Determine the maximum tolerated dose of paclitaxel, carboplatin, and ifosfamide when
given with a high-dose treatment program in these patients. (Phase I)

- Determine the efficacy of this regimen when given as salvage therapy in the second-line
or third-line setting, in terms of complete response, in these patients. (Phase II)

OUTLINE: This is a phase I, dose-escalation study of paclitaxel, carboplatin, and ifosfamide
followed by a phase II, open-label study.

- Phase I:

- Paclitaxel, ifosfamide, and autologous peripheral blood stem cell (PBSC)
collection: Patients receive paclitaxel IV over 3 hours on day 1 and ifosfamide IV
over 2 hours on days 1-3. Patients undergo leukapheresis on days 11-13. Patients
also receive filgrastim (G-CSF) subcutaneously (SC) twice daily beginning on day 3
and continuing until leukapheresis is completed. Beginning on day 14 or 21,
patients may receive a second course of paclitaxel, ifosfamide, and G-CSF.
Patients may also undergo additional leukapheresis.

- Paclitaxel, carboplatin, ifosfamide, and autologous PBSC transplantation: Patients
receive paclitaxel IV over 3 hours, high-dose carboplatin IV over 30 minutes, and
ifosfamide IV over 4 hours on days 1-3. Patients also receive G-CSF SC beginning
on day 3 and continuing until blood counts recover. Patients undergo reinfusion of
autologous PBSCs on day 5. Treatment repeats every 21-28 days for 3 courses in the
absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of paclitaxel, carboplatin, and ifosfamide
until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose
preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

- Phase II: Patients receive treatment as in phase I with paclitaxel, carboplatin, and
ifosfamide at the MTD determined in phase I.

After completion of study treatment, patients are followed periodically for 1 year and then
annually thereafter.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed germ cell tumor (GCT)

- Primary CNS GCT allowed

- Unidimensionally measurable disease OR elevated serum tumor markers
(alpha-fetoprotein and/or human chorionic gonadotropin)

- Advanced disease

- Disease resistant to a cisplatin-based chemotherapy regimen (i.e., failed to
achieve a durable complete response to cisplatin)

- Known residual disease after post-chemotherapy surgery allowed

PATIENT CHARACTERISTICS:

- Platelet count ≥ 100,000/mm^3

- WBC ≥ 3,000/mm^3

- Creatinine clearance > 50 mL/min (unless due to tumor obstructing the ureters)

- AST and ALT < 2 times upper limit of normal (ULN)

- Bilirubin < 1.5 times ULN

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No active infection

- Negative serology for HIV type I and II, human T-lymphotropic virus type I and II,
hepatitis B or C virus, syphilis, and cytomegalovirus

- Hepatitis C negative serology by RIBA or PCR

- Adequate medical condition for general anesthesia

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- Recovered from recent surgery

- At least 3 weeks since prior chemotherapy

- No prior high-dose therapy with autologous bone marrow transplantation

- No other concurrent chemotherapy

- No other concurrent treatment (e.g., surgery or radiotherapy)

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response (complete and partial)

Outcome Time Frame:

2 year

Safety Issue:

No

Principal Investigator

Darren Feldman, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

06-077

NCT ID:

NCT00423852

Start Date:

August 2006

Completion Date:

February 2013

Related Keywords:

  • Brain and Central Nervous System Tumors
  • Extragonadal Germ Cell Tumor
  • Ovarian Cancer
  • Teratoma
  • Testicular Germ Cell Tumor
  • recurrent ovarian germ cell tumor
  • stage III ovarian germ cell tumor
  • stage IV ovarian germ cell tumor
  • recurrent malignant testicular germ cell tumor
  • adult central nervous system germ cell tumor
  • stage III malignant testicular germ cell tumor
  • stage II malignant testicular germ cell tumor
  • recurrent extragonadal non-seminomatous germ cell tumor
  • recurrent extragonadal seminoma
  • stage III extragonadal non-seminomatous germ cell tumor
  • stage III extragonadal seminoma
  • stage IV extragonadal non-seminomatous germ cell tumor
  • stage IV extragonadal seminoma
  • recurrent extragonadal germ cell tumor
  • adult teratoma
  • testicular immature teratoma
  • testicular mature teratoma
  • Nervous System Neoplasms
  • Ovarian Neoplasms
  • Teratoma
  • Central Nervous System Neoplasms
  • Neoplasms, Germ Cell and Embryonal

Name

Location
Memorial Sloan-Kettering Cancer Center New York, New York  10021