Efaproxiral Plus Carmustine in Treating Patients With Progressive or Recurrent Malignant Glioma
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Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of efaproxiral when given with carmustine and to see how well they work in treating patients with progressive or recurrent malignant glioma.
| Condition | Intervention | Phase |
|---|---|---|
|
Brain and Central Nervous System Tumors |
Drug: carmustine Drug: efaproxiral |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase I/II Study to Evaluate the Safety and Tolerance of Escalating Doses of RSR13 Administered With a Fixed Dose of BCNU Every Six Weeks in Patients With Recurrent Malignant Glioma |
- Safety and tolerability [ Designated as safety issue: Yes ]
- Maximum tolerated dose [ Designated as safety issue: Yes ]
- Pharmacokinetic profile [ Designated as safety issue: No ]
- Efficacy [ Designated as safety issue: No ]
| Estimated Enrollment: | 48 |
| Study Start Date: | July 2000 |
OBJECTIVES:
- Evaluate the safety and tolerability of escalating doses of efaproxiral (RSR13) when administered concurrently with carmustine in patients with progressive or recurrent malignant glioma.
- Determine the maximum tolerated dose (MTD) of RSR13 when administered with carmustine in this patient population.
- Determine the pharmacokinetic profile of this regimen in these patients.
- Estimate the efficacy of this regimen at the MTD in these patients.
OUTLINE: This is a nonrandomized, open-label, multicenter, dose-escalation study of efaproxiral (RSR13).
Patients receive RSR13 IV over 30 minutes followed 30 minutes later by carmustine IV over 1-2 hours on day 1. Treatment repeats every 6 weeks for a maximum of 6 courses in the absence of unacceptable toxicity or disease progression.
Cohorts of 6-12 patients receive escalating doses of RSR13 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 3 of 6 or 5 of 12 patients experience dose-limiting toxicity. Once the MTD is determined, additional patients are accrued to receive treatment with RSR13 and carmustine at the recommended phase II dose.
Patients are followed at 6 weeks and then every 2 months thereafter.
PROJECTED ACCRUAL: A maximum of 48 patients will be accrued for the phase I portion of this study. A maximum of 47 patients will be accrued for the phase II portion of this study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed malignant glioma that is progressive or recurrent after radiotherapy with or without chemotherapy
- Anaplastic astrocytoma
- Anaplastic oligodendroglioma
- Glioblastoma multiforme
- Prior low-grade glioma allowed provided progression has occurred after radiotherapy with or without chemotherapy and then high-grade glioma is found on biopsy
- Measurable disease by serial MRI or CT scan
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- Karnofsky 60-100%
Life expectancy:
- Not specified
Hematopoietic:
- Absolute neutrophil count at least 1,500/mm^3
- Hemoglobin at least 10 g/dL
- Platelet count at least 100,000/mm^3
Hepatic:
- Bilirubin no greater than 2.0 mg/dL
- Alkaline phosphatase no greater than 3 times upper limit of normal (ULN)
- SGOT and SGPT no greater than 3 times ULN
Renal:
- Creatinine no greater than 2.0 mg/dL
Pulmonary:
- Resting oxygen saturation on room air at least 90% by pulse oximetry
- FVC, DLCO, and FEV_1 at least 50% of normal
Other:
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No other serious concurrent medical illness that would preclude study compliance
- No other prior malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- At least 3 weeks since prior investigational biologics
Chemotherapy:
- See Disease Characteristics
- No prior nitrosoureas for glioma
- No more than 1 prior chemotherapy regimen
- At least 4 weeks since prior chemotherapy
- No prior efaproxiral
Endocrine therapy:
- Concurrent corticosteroids (e.g., dexamethasone) allowed
Radiotherapy:
- See Disease Characteristics
- At least 90 days since prior radiotherapy
Surgery:
- Not specified
Other:
- At least 3 weeks since other prior investigational drugs or devices
Contacts and Locations| United States, Alabama | |
| University of Alabama at Birmingham Comprehensive Cancer Center | |
| Birmingham, Alabama, United States, 35294 | |
| United States, Florida | |
| H. Lee Moffitt Cancer Center and Research Institute at University of South Florida | |
| Tampa, Florida, United States, 33612-9497 | |
| United States, Georgia | |
| Winship Cancer Institute of Emory University | |
| Atlanta, Georgia, United States, 30322 | |
| United States, Maryland | |
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | |
| Baltimore, Maryland, United States, 21231-2410 | |
| United States, Massachusetts | |
| Massachusetts General Hospital Cancer Center | |
| Boston, Massachusetts, United States, 02114 | |
| United States, Michigan | |
| Josephine Ford Cancer Center at Henry Ford Hospital | |
| Detroit, Michigan, United States, 48202 | |
| United States, North Carolina | |
| Wake Forest University Comprehensive Cancer Center | |
| Winston-Salem, North Carolina, United States, 27157-1096 | |
| United States, Pennsylvania | |
| Abramson Cancer Center of the University of Pennsylvania | |
| Philadelphia, Pennsylvania, United States, 19104-4283 | |
| United States, Texas | |
| University of Texas Health Science Center at San Antonio | |
| San Antonio, Texas, United States, 78229-3900 | |
| Study Chair: | Pamela Z. New, MD | The University of Texas Health Science Center, Houston |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00005855 History of Changes |
| Other Study ID Numbers: | CDR0000067881, NABTT-9806, JHOC-NABTT-9806 |
| Study First Received: | June 2, 2000 |
| Last Updated: | July 23, 2008 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
adult glioblastoma adult anaplastic astrocytoma adult anaplastic oligodendroglioma |
recurrent adult brain tumor adult giant cell glioblastoma adult gliosarcoma |
Additional relevant MeSH terms:
|
Nervous System Neoplasms Central Nervous System Neoplasms Glioma Neoplasms by Site Neoplasms Nervous System Diseases Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue |
Carmustine Efaproxiral Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Antisickling Agents Hematologic Agents Radiation-Sensitizing Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 23, 2013