Chemotherapy in Treating Patients With Advanced Solid Tumors
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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.
PURPOSE: Phase I trial to study the effectiveness of temozolomide in treating patients who have advanced solid tumors.
| Condition | Intervention | Phase |
|---|---|---|
|
Unspecified Adult Solid Tumor, Protocol Specific |
Drug: temozolomide |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase I Study of Cyclic Oral Administration of SCH 52365 for 21 of 28 Days in Patients With Advanced Solid Malignancies |
| Enrollment: | 32 |
| Study Start Date: | July 1998 |
| Study Completion Date: | May 2000 |
| Primary Completion Date: | May 2000 (Final data collection date for primary outcome measure) |
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Drug: temozolomide
- Temodar
- Temodal
- Temcad
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Histologically or cytologically proven solid malignancy for which no curative therapy exists Glioblastoma eligible if following criteria are met: Stable performance status Stable symptoms At least 4 weeks on stable dose of dexamethasone CNS metastases allowed if no progression or no new edema present Measurable or evaluable disease No acute or chronic leukemia or multiple myeloma No known bone marrow involvement with tumor
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
Contacts and Locations| United States, Texas | |
| Brooke Army Medical Center | |
| Fort Sam Houston, Texas, United States, 78234 | |
| San Antonio Cancer Institute | |
| San Antonio, Texas, United States, 78229 | |
| Study Chair: | Anthony W. Tolcher, MD | San Antonio Cancer Institute |
More Information
Additional Information:
No publications provided
| Responsible Party: | The University of Texas Health Science Center at San Antonio |
| ClinicalTrials.gov Identifier: | NCT00003708 History of Changes |
| Other Study ID Numbers: | CDR0000066816, P30CA054174, UTHSC-9785011336, SACI-IDD-98-09, SPRI-C98-247, NCI-V98-1502 |
| Study First Received: | November 1, 1999 |
| Last Updated: | August 7, 2012 |
| Health Authority: | United States: Food and Drug Administration United States: Institutional Review Board |
Keywords provided by The University of Texas Health Science Center at San Antonio:
|
unspecified adult solid tumor, protocol specific |
Additional relevant MeSH terms:
|
Neoplasms Temozolomide Antineoplastic Agents, Alkylating Alkylating Agents |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 19, 2013