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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


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Brain and Central Nervous System Tumors

Thank you

Trial Information

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


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.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Safety and tolerability

Safety Issue:

Yes

Principal Investigator

Pamela Z. New, MD

Investigator Role:

Study Chair

Investigator Affiliation:

The University of Texas Health Science Center, Houston

Authority:

United States: Federal Government

Study ID:

CDR0000067881

NCT ID:

NCT00005855

Start Date:

July 2000

Completion Date:

October 2006

Related Keywords:

  • Brain and Central Nervous System Tumors
  • adult glioblastoma
  • adult anaplastic astrocytoma
  • adult anaplastic oligodendroglioma
  • recurrent adult brain tumor
  • adult giant cell glioblastoma
  • adult gliosarcoma
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms
  • Glioma

Name

Location

University of Texas Health Science Center at San AntonioSan Antonio, Texas  78284-7811
Abramson Cancer Center of the University of PennsylvaniaPhiladelphia, Pennsylvania  19104-4283
Massachusetts General Hospital Cancer CenterBoston, Massachusetts  02114
University of Alabama at Birmingham Comprehensive Cancer CenterBirmingham, Alabama  35294-3300
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland  21231-2410
Josephine Ford Cancer Center at Henry Ford HospitalDetroit, Michigan  48202
Winship Cancer Institute of Emory UniversityAtlanta, Georgia  30322
Wake Forest University Comprehensive Cancer CenterWinston-Salem, North Carolina  27157-1096
H. Lee Moffitt Cancer Center and Research Institute at University of South FloridaTampa, Florida  33612