NCT00019344

Brief Summary

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 flavopiridol in treating patients who have refractory cancer.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 1997

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

July 11, 2001

Completed
2.8 years until next milestone

First Posted

Study publicly available on registry

April 21, 2004

Completed
Last Updated

April 29, 2015

Status Verified

May 1, 2002

First QC Date

July 11, 2001

Last Update Submit

April 28, 2015

Conditions

LymphomaProstate CancerSmall Intestine CancerUnspecified Adult Solid Tumor, Protocol Specific

Keywords

stage IV adult Hodgkin lymphomarecurrent adult Hodgkin lymphomastage IV cutaneous T-cell non-Hodgkin lymphomarecurrent cutaneous T-cell non-Hodgkin lymphomasmall intestine lymphomastage IV prostate cancerrecurrent prostate cancerunspecified adult solid tumor, protocol specificstage IV grade 1 follicular lymphomastage IV grade 2 follicular lymphomastage IV grade 3 follicular lymphomastage IV adult diffuse small cleaved cell lymphomastage IV adult diffuse mixed cell lymphomastage IV adult diffuse large cell lymphomastage IV adult immunoblastic large cell lymphomastage IV adult lymphoblastic lymphomastage IV adult Burkitt lymphomarecurrent grade 1 follicular lymphomarecurrent grade 2 follicular lymphomarecurrent grade 3 follicular lymphomarecurrent adult diffuse small cleaved cell lymphomarecurrent adult diffuse mixed cell lymphomarecurrent adult diffuse large cell lymphomarecurrent adult immunoblastic large cell lymphomarecurrent adult lymphoblastic lymphomarecurrent adult Burkitt lymphomastage IV adult T-cell leukemia/lymphomarecurrent adult T-cell leukemia/lymphomaintraocular lymphomastage IV mantle cell lymphomarecurrent mantle cell lymphomaangioimmunoblastic T-cell lymphomaanaplastic large cell lymphomastage IV mycosis fungoides/Sezary syndromerecurrent mycosis fungoides/Sezary syndromerecurrent marginal zone lymphomarecurrent small lymphocytic lymphomastage IV small lymphocytic lymphomastage IV marginal zone lymphomaextranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissuenodal marginal zone B-cell lymphomasplenic marginal zone lymphoma

Interventions

alvocidibDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Medicine Branch

Bethesda, Maryland, 20892, United States

Location

Related Publications (1)

  • Senderowicz AM, Messmann R, Arbuck S, et al.: A phase I trial of 1 hour infusion of flavopiridol (FLA), a novel cyclin-dependent Kinase inhibitor, in patients with advanced neoplasms. [Abstract] Proceedings of the American Society of Clinical Oncology 19: A-796, 2000.

    RESULT

MeSH Terms

Conditions

LymphomaProstatic NeoplasmsHodgkin DiseaseLymphoma, T-Cell, CutaneousLymphoma, FollicularLymphoma, Non-HodgkinLymphoma, Large B-Cell, DiffuseLymphoma, Large-Cell, ImmunoblasticPrecursor Cell Lymphoblastic Leukemia-LymphomaBurkitt LymphomaPrecursor T-Cell Lymphoblastic Leukemia-LymphomaIntraocular LymphomaLymphoma, Mantle-CellImmunoblastic LymphadenopathyLymphoma, Large-Cell, AnaplasticMycosis FungoidesSezary SyndromeLymphoma, B-Cell, Marginal ZoneLeukemia, Lymphocytic, Chronic, B-Cell

Interventions

alvocidib

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesGenital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesLymphoma, T-CellLymphoma, B-CellLeukemia, LymphoidLeukemiaHematologic DiseasesEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsEye NeoplasmsLymphadenopathyLeukemia, B-CellChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Edward A. Sausville, MD, PhD

    National Cancer Institute (NCI)

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

July 11, 2001

First Posted

April 21, 2004

Study Start

August 1, 1997

Last Updated

April 29, 2015

Record last verified: 2002-05

Locations

US(1)