Paclitaxel, Ifosfamide, and Carboplatin Followed By Autologous Stem Cell Transplant in Treating Patients With Germ Cell Tumors That Did Not Respond to Cisplatin
This study has been completed.
Sponsor:
Memorial Sloan-Kettering Cancer Center
Collaborator:
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00423852
First received: January 16, 2007
Last updated: February 6, 2013
Last verified: February 2013
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Purpose
RATIONALE: Drugs used in chemotherapy, such as paclitaxel, ifosfamide, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. An autologous peripheral stem cell transplant may be able to replace blood-forming cells that were destroyed by chemotherapy. This may allow more chemotherapy to be given so that more tumor cells are killed.
PURPOSE: This phase I/II trial is studying the side effects and best dose of ifosfamide when given together with paclitaxel and carboplatin followed by an autologous stem cell transplant and to see how well they work in treating patients with germ cell tumors that did not respond to cisplatin.
| Condition | Intervention | Phase |
|---|---|---|
|
Brain and Central Nervous System Tumors Extragonadal Germ Cell Tumor Ovarian Cancer Teratoma Testicular Germ Cell Tumor |
Biological: filgrastim Drug: carboplatin Drug: ifosfamide Drug: paclitaxel Procedure: autologous hematopoietic stem cell transplantation Procedure: peripheral blood stem cell transplantation |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 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 |
Resource links provided by NLM:
Drug Information available for:
Ifosfamide
Cisplatin
Paclitaxel
Carboplatin
Filgrastim
Lenograstim
Granulocyte colony-stimulating factor
U.S. FDA Resources
Further study details as provided by Memorial Sloan-Kettering Cancer Center:
Primary Outcome Measures:
- Response (complete and partial) [ Time Frame: 2 year ] [ Designated as safety issue: No ]
- Maximum tolerated dose of paclitaxel, carboplatin, and ifosfamide [ Time Frame: 2 year ] [ Designated as safety issue: Yes ]
- Efficacy [ Time Frame: 2 year ] [ Designated as safety issue: No ]
- Safety [ Time Frame: 2 year ] [ Designated as safety issue: Yes ]
| Enrollment: | 26 |
| Study Start Date: | August 2006 |
| Study Completion Date: | February 2013 |
| Primary Completion Date: | February 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: chemotherapy with Stem Cell Support
This is a phase I/II trial of sequential accelerated chemotherapy cycles with paclitaxel/ifosfamide and paclitaxel/ifosfamide and carboplatin administered with G-CSF and PBSC support. During phase I, carboplatin, ifosfamide, and paclitaxel will be dose escalated to determine the MTD. Additional patients will be enrolled in the Phase II portion of the study following the determination of the MTD of Ifosfamide and paclitaxel, to bring the total possible number of patients treated at the MTD to 38.
|
Biological: filgrastim Drug: carboplatin Drug: ifosfamide Drug: paclitaxel Procedure: autologous hematopoietic stem cell transplantation Procedure: peripheral blood stem cell transplantation |
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00423852
Locations
| United States, New York | |
| Memorial Sloan-Kettering Cancer Center | |
| New York, New York, United States, 10065 | |
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
| Principal Investigator: | Darren Feldman, MD | Memorial Sloan-Kettering Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | Memorial Sloan-Kettering Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00423852 History of Changes |
| Other Study ID Numbers: | 06-077, MSKCC-06077 |
| Study First Received: | January 16, 2007 |
| Last Updated: | February 6, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Memorial Sloan-Kettering Cancer Center:
|
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 |
Additional relevant MeSH terms:
|
Nervous System Neoplasms Ovarian Neoplasms Teratoma Central Nervous System Neoplasms Neoplasms, Germ Cell and Embryonal Neoplasms by Site Neoplasms Nervous System Diseases Endocrine Gland Neoplasms Ovarian Diseases Adnexal Diseases Genital Diseases, Female Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases |
Gonadal Disorders Neoplasms by Histologic Type Isophosphamide mustard Cisplatin Ifosfamide Carboplatin Paclitaxel Lenograstim Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Antineoplastic Agents, Alkylating Alkylating Agents |
ClinicalTrials.gov processed this record on May 21, 2013