NCT00019656

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 perifosine in treating patients who have refractory solid tumors or hematologic cancer.

Trial Health

80
On Track

Trial Health Score

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

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 1999

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

July 11, 2001

Completed
1.5 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
Last Updated

April 29, 2015

Status Verified

August 1, 2004

First QC Date

July 11, 2001

Last Update Submit

April 28, 2015

Conditions

LeukemiaLymphomaMyelodysplastic SyndromesMyelodysplastic/Myeloproliferative NeoplasmsUnspecified Adult Solid Tumor, Protocol Specific

Keywords

stage IV chronic lymphocytic leukemiarefractory chronic lymphocytic leukemiaunspecified adult solid tumor, protocol specificpreviously treated myelodysplastic syndromesde novo myelodysplastic syndromesrecurrent adult diffuse large cell lymphomarecurrent adult diffuse mixed cell lymphomarecurrent adult diffuse small cleaved cell lymphomarecurrent adult Burkitt lymphomarecurrent adult Hodgkin lymphomarecurrent adult immunoblastic large cell lymphomarecurrent adult lymphoblastic lymphomarecurrent grade 1 follicular lymphomarecurrent grade 2 follicular lymphomarecurrent grade 3 follicular lymphomarecurrent mantle cell lymphomasecondary myelodysplastic syndromesstage IV adult diffuse large cell lymphomastage IV adult diffuse mixed cell lymphomastage IV adult diffuse small cleaved cell lymphomastage IV adult Burkitt lymphomastage IV adult Hodgkin lymphomastage IV adult immunoblastic large cell lymphomastage IV adult lymphoblastic lymphomastage IV grade 1 follicular lymphomastage IV grade 2 follicular lymphomastage IV grade 3 follicular lymphomastage IV mantle cell lymphomachronic myelomonocytic leukemiaatypical chronic myeloid leukemia, BCR-ABL1 negativemyelodysplastic/myeloproliferative neoplasm, unclassifiablerecurrent 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

perifosineDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed solid tumor, non-Hodgkin's lymphoma, chronic lymphocytic leukemia, myelodysplastic syndromes, or Hodgkin's lymphoma that has no effective standard therapeutic option but requires systemic therapy * No history of CNS neoplasms * For prostate cancer: * Tumor progression during blockade of testicular and adrenal androgens * At least 4 weeks since prior flutamide or other antiandrogens without disease improvement * Leuprolide or other gonadotropin-releasing hormones should be maintained in patients without an orchiectomy * Testosterone in the castrate range * For breast cancer: * At least 4 weeks since any prior hormonal therapy with evidence of disease progression PATIENT CHARACTERISTICS: Age: * Over 18 Performance status: * ECOG 0-2 Life expectancy: * Not specified Hematopoietic: * Platelet count greater than 50,000/mm\^3 * Absolute granulocyte count greater than 500/mm\^3 * Hemoglobin at least 9.0 g/dL Hepatic: * Bilirubin no greater than 1.5 mg/dL * SGOT and SGPT no greater than 2.5 times normal 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 the past 6 months * No New York Heart Association class II-IV heart disease Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * HIV negative * No recent acute or chronic gastrointestinal conditions (e.g., stomach ulcer or enteritis) that might affect tolerability or drug absorption * No allergic reaction to any medication with a structure similar to perifosine * No pre-existing retinal disease or pathologic baseline electrooculogram * No cataracts that would interfere with normal vision or require medical intervention * No other serious concurrent illness that would preclude assessment of drug effect PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered * At least 2 months since prior UCN-01 * More than 3 months since prior suramin Endocrine therapy: * See Disease Characteristics * No concurrent corticosteroids except for physiological replacement or as antiemetics Radiotherapy: * At least 4 weeks since prior radiotherapy (6 weeks for bone-seeking radioisotopes) and recovered Surgery: * See Disease Characteristics Other: * No other concurrent antineoplastic therapies

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

Sponsors & Collaborators

Study Sites (2)

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Bethesda, Maryland, 20892-1182, United States

Location

NCI - Center for Cancer Research

Bethesda, Maryland, 20892, United States

Location

Related Publications (2)

  • Monga M, Messmann RA, Headlee D, et al.: A phase I trial of oral perifosine in patients with refractory neoplasms. [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-1837, 7b, 2002.

    RESULT

  • Messmann RA, Headlee D, Woo EW, et al.: A phase I trial of oral perifosine with different loading and maintenance schedules in patients with refractory neoplasms. [Abstract] Proc Am Assoc Cancer Res 42: A-2880, 2001.

    RESULT

MeSH Terms

Conditions

LeukemiaLymphomaMyelodysplastic SyndromesMyelodysplastic-Myeloproliferative DiseasesLeukemia, Lymphocytic, Chronic, B-CellLymphoma, Large B-Cell, DiffuseLymphoma, Non-HodgkinBurkitt LymphomaHodgkin DiseaseLymphoma, Large-Cell, ImmunoblasticPrecursor Cell Lymphoblastic Leukemia-LymphomaLymphoma, FollicularLymphoma, Mantle-CellLeukemia, Myelomonocytic, ChronicLeukemia, Myeloid, Chronic, Atypical, BCR-ABL NegativeMyeloproliferative DisordersLymphoma, B-Cell, Marginal Zone

Interventions

perifosine

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesBone Marrow DiseasesLeukemia, B-CellLeukemia, LymphoidChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsLymphoma, B-CellEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsLeukemia, Myeloid

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

January 27, 2003

Study Start

August 1, 1999

Last Updated

April 29, 2015

Record last verified: 2004-08

Locations

US(2)