Chemotherapy in Treating Patients With Advanced Solid Tumors

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

1998-07-31

Study Completion Date

2000-05-31

Brief Summary

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RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase I trial to study the effectiveness of temozolomide in treating patients who have advanced solid tumors.

Detailed Description

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OBJECTIVES: I. Determine the safety, tolerability, maximum tolerated dose, and dose limiting toxicity of temozolomide in patients with advanced solid malignancies. II. Characterize the single- and multiple-dose pharmacokinetics of temozolomide following oral administration in these patients. III. Determine antitumor activity of temozolomide in these patients.

OUTLINE: This is an open label, dose escalation study. Patients receive oral temozolomide on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients are treated at escalating doses of temozolomide. The maximum tolerated dose is defined as the dose at which no more than 1 of 6 patients experiences dose limiting toxicity (DLT) during courses 1 or 2, with at least 2 patients experiencing DLT at the next higher dose level.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.

Conditions

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Unspecified Adult Solid Tumor, Protocol Specific

Keywords

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unspecified adult solid tumor, protocol specific

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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temozolomide

Patients receive oral temozolomide on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients are treated at escalating doses of temozolomide. The maximum tolerated dose is defined as the dose at which no more than 1 of 6 patients experiences dose limiting toxicity (DLT) during courses 1 or 2, with at least 2 patients experiencing DLT at the next higher dose level.

Intervention Type DRUG

Other Intervention Names

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Temodar Temodal Temcad

Eligibility Criteria

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Inclusion Criteria

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count greater than 1500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 9 g/dL Hepatic: Bilirubin no greater than 2.0 mg/dL SGOT or SGPT no greater than 3 times upper limit of normal (ULN) (5 times ULN if due to liver metastases) Renal: Creatinine no greater than 1.5 mg/dL Other: No malabsorption syndrome due to prior surgery, gastrointestinal disease, or other unknown reason No concurrent nonmalignant systemic disease No active uncontrolled infection No frequent vomiting or medical condition that could interfere with oral medication uptake (e.g., partial bowel obstruction, bowel resection, partial intestinal bypass, external biliary diversion) No prior or concurrent malignancies at other sites except carcinoma in situ of the cervix or adequately treated basal or squamous cell skin cancer HIV negative No AIDS-related illness Not pregnant or nursing Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior biologic therapy and recovered No prior allogeneic, syngeneic, or autologous bone marrow transplantation No prior peripheral blood stem cell transplantation No concurrent biologic therapy Chemotherapy: At least 4 weeks since prior chemotherapy (6 weeks for nitrosourea or mitomycin) and recovered No concurrent chemotherapy Endocrine therapy: See Disease Characteristics Radiotherapy: At least 4 weeks since prior radiotherapy to at least 25% of bone marrow (including pelvic irradiation) and recovered No concurrent radiotherapy Surgery: Prior major gastrointestinal surgery allowed (e.g., Whipple procedure) Other: At least 4 weeks since any prior investigational therapy At least 24 hours since prior alcohol consumption

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anthony W. Tolcher, MD

Role: STUDY_CHAIR

San Antonio Cancer Institute

Locations

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Brooke Army Medical Center

Fort Sam Houston, Texas, United States

Site Status

San Antonio Cancer Institute

San Antonio, Texas, United States

Site Status

Countries

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United States