Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Stanford, California 94305


Purpose:

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of carmustine in treating patients who have progressive or recurrent glioblastoma multiforme.


Study summary:

OBJECTIVES: - Determine the maximum tolerated dose of intratumoral carmustine in ethanol (DTI-015) in patients with unresectable recurrent glioblastoma multiforme. (Phase I of this study closed to accrual as of 01/15/2002.) - Determine the qualitative and quantitative toxicity of this regimen in these patients. - Assess the activity of this regimen in these patients. - Estimate peripheral blood carmustine levels in these patients treated with this regimen. OUTLINE: This is a dose-escalation, multicenter study. Patients receive carmustine in ethanol (DTI-015) intratumorally over 5 minutes during stereotactic biopsy or open craniotomy. Cohorts of 3-6 patients receive escalating doses of DTI-015 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 3 of 6 patients experience dose-limiting toxicity. (Phase I of this study closed to accrual as of 01/15/2002.) Additional patients then receive treatment with DTI-015 at the recommended phase II dose. Patients are followed at 4, 8, and 12 weeks and then every 1-3 months until disease progression. PROJECTED ACCRUAL: A total of 12 patients were accrued for phase I of this study and approximately 14-18 patients will be accrued for phase II of this study. (Phase I of this study closed to accrual as of 01/15/2002.)


Criteria:

DISEASE CHARACTERISTICS: - Histologically proven supratentorial malignant glioblastoma multiforme - Clear evidence of disease progression by MRI - Unresectable tumor that has spherical, spheroid, or ovoid shape (not multicentric or multilobulated) - Central necrosis and/or central cystic areas allowed in the presence of enhancing rim thickness greater than 5 mm - No brainstem (pons or medulla) or midbrain (mesencephalon) involvement - No involvement of primary sensorimotor cortex in the dominant hemisphere or within 1.5 cm of the optic chiasm, either optic nerve, or any other cranial nerve - No tumor extension into the ventricular system - Tumor volume no greater than 33.4 cm3 - At least one prior radiotherapy PATIENT CHARACTERISTICS: Age: - 18 to 75 Performance status: - Karnofsky 60-100% Life expectancy: - Not specified Hematopoietic: - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 - No evidence of bleeding diathesis Hepatic: - Bilirubin no greater than 2.0 mg/dL - SGOT/SGPT no greater than 2.5 times normal Renal: - Creatinine no greater than 2.0 mg/dL OR - Creatinine clearance at least 40 mL/min - BUN no greater than 30 mg/dL Other: - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No active uncontrolled infection - Afebrile unless fever due to presence of tumor - No other concurrent serious medical or psychiatric illness that would preclude study PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin including Gliadel wafer therapy) and recovered Endocrine therapy: - Not specified Radiotherapy: - See Disease Characteristics - At least 4 weeks since prior radiotherapy and recovered - No prior intracranial brachytherapy Surgery: - Recovered from any prior surgery Other: - No prior anticoagulants - No other concurrent investigational agents


Study is Available At:


Original ID:

CDR0000068207


NCT ID:

NCT00006656


Secondary ID:

DTI-9901


Study Acronym:


Brief Title:

Carmustine in Treating Patients With Progressive or Recurrent Glioblastoma Multiforme


Official Title:

A Phase I/II Study of the Safety and Tolerability of DTI-015 in Patients With Recurrent Glioblastoma Multiforme


Overall Status:

Active, not recruiting


Study Phase:

Phase 2


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

75 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

National Cancer Institute (NCI)


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Primary Purpose: Treatment


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

0


Enrollment Type:


Overall Contact Information

Official Name:Gene David Resnick, MD
Study Chair
Millennix

Study Dates

Start Date:June 2000
Verification Date:August 2003
Last Changed Date:November 5, 2013
First Received Date:December 6, 2000

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Drug
Name:carmustine in ethanol
Intervention Type:Procedure
Name:conventional surgery

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Direct Therapeutics

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


This study is not currently recruiting Study Participants. The form below is not enabled.