A Phase I Trial of Daily Bolus Flavopiridol for Five Consecutive Days in Patients With Refractory Neoplasms
18 Years
N/A
Both
Lymphoma, Prostate Cancer, Small Intestine Cancer, Unspecified Adult Solid Tumor, Protocol Specific
Trial Information
A Phase I Trial of Daily Bolus Flavopiridol for Five Consecutive Days in Patients With Refractory Neoplasms
OBJECTIVES: I. Determine the dose-limiting toxicity and maximum tolerated dose of
flavopiridol in patients with refractory solid tumors or lymphoma. 2. Determine the
pharmacokinetics of this drug in these patients.
OUTLINE: This is a dose-escalation study. Patients receive flavopiridol IV over 1 hour on
day 1. Treatment continues every 3 weeks in the absence of disease progression. A cohort of
3-6 patients receives treatment at each dose level of flavopiridol. If dose-limiting
toxicity (DLT) occurs in no more than 1 of 6 patients, subsequent cohorts of 6 patients each
receive escalating doses of drug on the same schedule. Intrapatient dose escalation to the
next level is permitted in the absence of DLT.
PROJECTED ACCRUAL: Approximately 36 patients will be accrued for this study within 27
months.
Inclusion Criteria
DISEASE CHARACTERISTICS: Histologically proven refractory solid tumor or lymphoma
requiring systemic therapy No standard therapeutic options exist Prostate cancer patients:
Tumor progression during blockade of testicular and adrenal androgen required PSA
elevation on 2 consecutive blood samples, 2 weeks apart Serum testosterone concentrations
in the castrate range Leuprolide or other gonadotropin-releasing hormone (GnRH) analogs
maintained if no prior orchiectomy No CNS neoplasms
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy:
Not specified Hematopoietic: Platelet count at least 75,000/mm3 Absolute granulocyte count
at least 1,000/mm3 No active coagulopathy requiring therapeutic anticoagulation Hepatic:
SGOT and SGPT no greater than 2.5 times normal Bilirubin no greater than 1.5 times normal
(3 times normal if Gilbert's disease present) Renal: Creatinine no greater than 1.5 mg/dL
OR Creatinine clearance at least 60 mL/min Cardiovascular: No history of unstable or newly
diagnosed angina pectoris No myocardial infarction within past 6 months No New York Heart
Association class II-IV heart disease Other: No serious concurrent medical illness HIV
negative Not pregnant or nursing Negative pregnancy test Fertile patients must use
effective contraception during and for 3 months after study
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 4 weeks
since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered No prior
flavopiridol Endocrine therapy: See Disease Characteristics A least 4 weeks since prior
flutamide or other antiandrogen therapy without disease improvement At least 4 weeks since
prior hormonal therapy for breast carcinoma and must show evidence of disease progression
No concurrent corticosteroids except for physiological replacement Radiotherapy: At least
4 weeks since prior radiotherapy and recovered At least 6 weeks since prior bone-seeking
radioisotope therapy Surgery: Not specified Other: At least 3 months since prior suramin
treatment At least 2 months since prior UCN-01 No concurrent anticoagulation therapy No
other concurrent antineoplastic therapy except for GnRH for prostate cancer
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Edward A. Sausville, MD, PhD
Investigator Role:
Study Chair
Investigator Affiliation:
National Cancer Institute (NCI)
Authority:
United States: Federal Government
Study ID:
CDR0000065779
NCT ID:
NCT00019344
Start Date:
August 1997
Completion Date:
Related Keywords:
- Lymphoma
- Prostate Cancer
- Small Intestine Cancer
- Unspecified Adult Solid Tumor, Protocol Specific
- stage IV adult Hodgkin lymphoma
- recurrent adult Hodgkin lymphoma
- stage IV cutaneous T-cell non-Hodgkin lymphoma
- recurrent cutaneous T-cell non-Hodgkin lymphoma
- small intestine lymphoma
- stage IV prostate cancer
- recurrent prostate cancer
- unspecified adult solid tumor, protocol specific
- stage IV grade 1 follicular lymphoma
- stage IV grade 2 follicular lymphoma
- stage IV grade 3 follicular lymphoma
- stage IV adult diffuse small cleaved cell lymphoma
- stage IV adult diffuse mixed cell lymphoma
- stage IV adult diffuse large cell lymphoma
- stage IV adult immunoblastic large cell lymphoma
- stage IV adult lymphoblastic lymphoma
- stage IV adult Burkitt lymphoma
- recurrent grade 1 follicular lymphoma
- recurrent grade 2 follicular lymphoma
- recurrent grade 3 follicular lymphoma
- recurrent adult diffuse small cleaved cell lymphoma
- recurrent adult diffuse mixed cell lymphoma
- recurrent adult diffuse large cell lymphoma
- recurrent adult immunoblastic large cell lymphoma
- recurrent adult lymphoblastic lymphoma
- recurrent adult Burkitt lymphoma
- stage IV adult T-cell leukemia/lymphoma
- recurrent adult T-cell leukemia/lymphoma
- intraocular lymphoma
- stage IV mantle cell lymphoma
- recurrent mantle cell lymphoma
- angioimmunoblastic T-cell lymphoma
- anaplastic large cell lymphoma
- stage IV mycosis fungoides/Sezary syndrome
- recurrent mycosis fungoides/Sezary syndrome
- recurrent marginal zone lymphoma
- recurrent small lymphocytic lymphoma
- stage IV small lymphocytic lymphoma
- stage IV marginal zone lymphoma
- extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
- nodal marginal zone B-cell lymphoma
- splenic marginal zone lymphoma
- Lymphoma
- Lymphoma, Non-Hodgkin
- Prostatic Neoplasms
- Lymphoma, Large-Cell, Immunoblastic
- Duodenal Neoplasms
- Ileal Neoplasms
- Jejunal Neoplasms
- Intestinal Neoplasms
Name | Location |
|---|---|
| Medicine Branch | Bethesda, Maryland 20892 |
