Clinical trial · Interventional
Perifosine in Treating Patients With Refractory Solid Tumors or Hematologic Cancer
A Phase I Trial of Oral Perifosine With Different Loading Schedules in Patients With Refractory Neoplasms
NCT00019656CI-TRIAL-00017685completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Myelodysplastic/Myeloproliferative Neoplasms | Myelodysplastic/Myeloproliferative Neoplasm | CURATED_BROADER | 0.80 |
| Myelodysplastic Syndromes | Myelodysplastic Syndrome | ALIAS | 0.90 |
| Unspecified Adult Solid Tumor, Protocol Specific | Adult Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| perifosine | Drug | Perifosine | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (2)
- RESULTMonga 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.
- RESULTMessmann 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.