Perifosine in Treating Patients With Refractory Solid Tumors or Hematologic Cancer
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| ClinicalTrials.gov Identifier: NCT00019656 |
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Recruitment Status :
Completed
First Posted : January 27, 2003
Last Update Posted : April 29, 2015
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Leukemia Lymphoma Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Neoplasms Unspecified Adult Solid Tumor, Protocol Specific | Drug: perifosine | Phase 1 |
OBJECTIVES:
- Determine the dose-limiting toxicity and maximum tolerated dose of perifosine administered as a varying series of loading and maintenance doses in patients with refractory solid tumors, non-Hodgkin's lymphoma, chronic lymphocytic leukemia, myelodysplastic syndromes, or Hodgkin's lymphoma.
- Determine the profile of adverse reactions (including changes in laboratory parameters) in patients treated with this regimen.
- Determine any disease responses that may occur in patients treated with this regimen.
- Determine the steady-state pharmacology and pharmacokinetics of this regimen in these patients.
OUTLINE: This is a dose-escalation study.
Patients receive a loading dose of oral perifosine on day 1 followed by a maintenance dose 2-3 times daily beginning on day 2 or 3 and continuing until day 21. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression.
Cohorts of 3-6 patients receive escalating loading and maintenance doses of perifosine until the maximum tolerated dose (MTD) of each is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, an additional 10 patients are treated at that dose level.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A maximum of 45 patients will be accrued for this study within 12-18 months.
| Study Type : | Interventional (Clinical Trial) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase I Trial of Oral Perifosine With Different Loading Schedules in Patients With Refractory Neoplasms |
| Study Start Date : | August 1999 |
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
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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
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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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00019656
| United States, Maryland | |
| Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support | |
| Bethesda, Maryland, United States, 20892-1182 | |
| NCI - Center for Cancer Research | |
| Bethesda, Maryland, United States, 20892 | |
| Study Chair: | Edward A. Sausville, MD, PhD | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00019656 |
| Obsolete Identifiers: | NCT00001799 |
| Other Study ID Numbers: |
CDR0000066960 NCI-99-C-0043 NCI-T98-0065 |
| First Posted: | January 27, 2003 Key Record Dates |
| Last Update Posted: | April 29, 2015 |
| Last Verified: | August 2004 |
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stage IV chronic lymphocytic leukemia refractory chronic lymphocytic leukemia unspecified adult solid tumor, protocol specific previously treated myelodysplastic syndromes de novo myelodysplastic syndromes recurrent adult diffuse large cell lymphoma recurrent adult diffuse mixed cell lymphoma recurrent adult diffuse small cleaved cell lymphoma recurrent adult Burkitt lymphoma recurrent adult Hodgkin lymphoma recurrent adult immunoblastic large cell lymphoma recurrent adult lymphoblastic lymphoma recurrent grade 1 follicular lymphoma recurrent grade 2 follicular lymphoma recurrent grade 3 follicular lymphoma |
recurrent mantle cell lymphoma secondary myelodysplastic syndromes stage IV adult diffuse large cell lymphoma stage IV adult diffuse mixed cell lymphoma stage IV adult diffuse small cleaved cell lymphoma stage IV adult Burkitt lymphoma stage IV adult Hodgkin lymphoma stage IV adult immunoblastic large cell lymphoma stage IV adult lymphoblastic lymphoma stage IV grade 1 follicular lymphoma stage IV grade 2 follicular lymphoma stage IV grade 3 follicular lymphoma stage IV mantle cell lymphoma chronic myelomonocytic leukemia atypical chronic myeloid leukemia, BCR-ABL1 negative |
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Lymphoma Leukemia Neoplasms Preleukemia Myelodysplastic Syndromes Myeloproliferative Disorders Myelodysplastic-Myeloproliferative Diseases Syndrome Neoplasms by Histologic Type |
Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Disease Pathologic Processes Bone Marrow Diseases Hematologic Diseases Precancerous Conditions |