Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00005855
Other study ID # CDR0000067881
Secondary ID NABTT-9806JHOC-N
Status Completed
Phase Phase 1/Phase 2
First received June 2, 2000
Last updated June 20, 2013
Start date July 2000
Est. completion date October 2006

Study information

Verified date December 2003
Source National Cancer Institute (NCI)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 48
Est. completion date October 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
carmustine

efaproxiral


Locations

Country Name City State
United States Winship Cancer Institute of Emory University Atlanta Georgia
United States Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Baltimore Maryland
United States University of Alabama at Birmingham Comprehensive Cancer Center Birmingham Alabama
United States Massachusetts General Hospital Cancer Center Boston Massachusetts
United States Josephine Ford Cancer Center at Henry Ford Hospital Detroit Michigan
United States Abramson Cancer Center of the University of Pennsylvania Philadelphia Pennsylvania
United States University of Texas Health Science Center at San Antonio San Antonio Texas
United States H. Lee Moffitt Cancer Center and Research Institute at University of South Florida Tampa Florida
United States Wake Forest University Comprehensive Cancer Center Winston-Salem North Carolina

Sponsors (2)

Lead Sponsor Collaborator
New Approaches to Brain Tumor Therapy Consortium National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Safety and tolerability Yes
Primary Maximum tolerated dose Yes
Primary Pharmacokinetic profile No
Primary Efficacy No
See also
  Status Clinical Trial Phase
Terminated NCT00788125 - Dasatinib, Ifosfamide, Carboplatin, and Etoposide in Treating Young Patients With Metastatic or Recurrent Malignant Solid Tumors Phase 1/Phase 2
Completed NCT00006080 - Fenretinide in Treating Patients With Recurrent Malignant Glioma Phase 2
Recruiting NCT00887146 - Radiation Therapy With Concomitant and Adjuvant Temozolomide Versus Radiation Therapy With Adjuvant PCV Chemotherapy in Patients With Anaplastic Glioma or Low Grade Glioma Phase 3
Suspended NCT00935090 - 3'-Deoxy-3'-[18F] Fluorothymidine PET Imaging in Patients With Cancer N/A
Completed NCT00621686 - Bevacizumab and Sorafenib in Treating Patients With Recurrent Glioblastoma Multiforme Phase 2
Completed NCT00112502 - Temozolomide Alone or in Combination With Thalidomide and/or Isotretinoin and/or Celecoxib in Treating Patients Who Have Undergone Radiation Therapy for Glioblastoma Multiforme Phase 2
Terminated NCT00227032 - Erlotinib in Treating Patients With Progressive Glioblastoma Multiforme Phase 1
Terminated NCT00243022 - Dietary, Herbal and Alternative Medicine in Glioblastoma Multiforme Phase 2
Active, not recruiting NCT00087815 - Hyperbaric Oxygen Therapy in Treating Patients With Radiation Necrosis of the Brain N/A
Active, not recruiting NCT00278278 - Combination Chemotherapy and Radiation Therapy With or Without Methotrexate in Treating Young Patients With Newly Diagnosed Gliomas Phase 3
Completed NCT00416819 - Combination Chemotherapy and Rituximab in Treating Patients With Newly Diagnosed Primary CNS Lymphoma N/A
Completed NCT00052286 - Modafinil in Treating Fatigue and Behavioral Change in Patients With Primary Brain Cancer N/A
Completed NCT00006093 - EMD 121974 in Treating Patients With Progressive or Recurrent Glioma Phase 1/Phase 2
Recruiting NCT00004129 - Phosphorus 32 in Treating Patients With Glioblastoma Multiforme Phase 1
Completed NCT00004212 - DX-8951f in Treating Children With Advanced Solid Tumors or Lymphomas Phase 1
Completed NCT00003417 - Computer Planned Radiation Therapy Plus Chemotherapy in Treating Patients With Glioblastoma Multiforme Phase 1/Phase 2
Completed NCT00003173 - High-Dose Thiotepa Plus Peripheral Stem Cell Transplantation in Treating Patients With Refractory Solid Tumors Phase 2
Completed NCT00008008 - Thiotepa Followed by Peripheral Stem Cell or Bone Marrow Transplant in Treating Patients With Malignant Glioma Phase 2
Completed NCT00003020 - LMB-7 Immunotoxin in Treating Patients With Leptomeningeal Metastases Phase 1
Completed NCT00003464 - Temozolomide in Treating Adults With Newly Diagnosed Primary Malignant Glioblastoma Multiforme Phase 2