Know Cancer

or
forgot password

A Phase I Trial of Daily Bolus Flavopiridol for Five Consecutive Days in Patients With Refractory Neoplasms


Phase 1
18 Years
N/A
Not Enrolling
Both
Lymphoma, Prostate Cancer, Small Intestine Cancer, Unspecified Adult Solid Tumor, Protocol Specific

Thank you

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 BranchBethesda, Maryland  20892