Clinical trial · Interventional
Perifosine in Treating Patients With Metastatic or Recurrent Malignant Melanoma
A Phase II Study Of Perifosine (D-21266) In Previously Untreated Patients With Metastatic Or Recurrent Malignant Melanoma
NCT00053781CI-TRIAL-00068537completedPhase 2ClinicalTrials.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 II trial to study the effectiveness of perifosine in treating patients who have metastatic or recurrent malignant melanoma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Melanoma (Skin) | Melanoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| perifosine | Drug | Perifosine | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed malignant melanoma * Metastatic or recurrent disease deemed incurable by standard therapies * Clinically and/or radiologically documented disease by at least 1 site that is unidimensionally measurable as follows: * At least 20 mm by x-ray or physical exam * At least 10 mm by spiral CT scan * At least 20 mm by non-spiral CT scan * Bone lesions are not considered measurable * Outside previously irradiated area unless evidence of progression or new lesions within irradiated field * No known brain metastases PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-2 Life expectancy * At least 12 weeks Hematopoietic * Absolute granulocyte count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic * Bilirubin no greater than upper limit of normal (ULN) * AST no greater than 2.5 times ULN Renal * Creatinine no greater than ULN Cardiovascular * No symptomatic congestive heart failure * No unstable angina pectoris * No cardiac arrhythmia Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No prior allergic reactions to compounds of similar chemical or biological composition to perifosine * No other malignancy within the past 5 years except adequately treated nonmelanoma skin cancer or curatively treated carcinoma in situ of the cervix * No ongoing or active infection * No other concurrent uncontrolled medical illness, psychiatric illness, or social situation that would preclude study entry PRIOR CONCURRENT THERAPY: Biologic therapy * At least 3 months since prior adjuvant immunotherapy * No prior immunotherapy for recurrent/metastatic disease Chemotherapy * No prior chemotherapy (including regional therapy) * No other concurrent cytotoxic chemotherapy Endocrine therapy * Not specified Radiotherapy * See Disease Characteristics * At least 4 weeks since prior radiotherapy (except for low-dose, nonmyelosuppressive radiotherapy) Surgery * At least 4 weeks since prior major surgery Other * No other concurrent anticancer therapy or investigational agents
References
Publications (1)
- RESULTErnst DS, Eisenhauer E, Wainman N, Davis M, Lohmann R, Baetz T, Belanger K, Smylie M. Phase II study of perifosine in previously untreated patients with metastatic melanoma. Invest New Drugs. 2005 Dec;23(6):569-75. doi: 10.1007/s10637-005-1157-4. PMID 16034524