Know Cancer

forgot password

A Phase I Study of Cyclic Oral Administration of SCH 52365 for 21 of 28 Days in Patients With Advanced Solid Malignancies

Phase 1
18 Years
Not Enrolling
Unspecified Adult Solid Tumor, Protocol Specific

Thank you

Trial Information

A Phase I Study of Cyclic Oral Administration of SCH 52365 for 21 of 28 Days in Patients With Advanced Solid Malignancies

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.

Inclusion Criteria

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

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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Anthony W. Tolcher, MD

Investigator Role:

Study Chair

Investigator Affiliation:

San Antonio Cancer Institute


United States: Food and Drug Administration

Study ID:




Start Date:

July 1998

Completion Date:

May 2000

Related Keywords:

  • Unspecified Adult Solid Tumor, Protocol Specific
  • unspecified adult solid tumor, protocol specific
  • Neoplasms



Brooke Army Medical Center Fort Sam Houston, Texas  78234-6200
San Antonio Cancer Institute San Antonio, Texas  78229-3264