Perifosine in Treating Patients With Metastatic or Recurrent Malignant Melanoma

• Sponsor: NCIC Clinical Trials Group (Other)
• Overall Status: Completed
• CT.gov ID: NCT00053781
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 18
• Locations: 6
• Actual Duration (Months): 79.2
• Patients Per Site: 3
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Melanoma (Skin)	Drug: perifosine	Phase 2

Detailed Description

OBJECTIVES:

• Determine the efficacy of perifosine, in terms of response rate, in previously untreated patients with metastatic or recurrent malignant melanoma.

• Assess the toxicity of this drug in these patients.

OUTLINE: This is a multicenter study.

Patients receive oral perifosine daily on days 1-21. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve a complete response (CR) or partial response (PR) receive 2 additional courses after documentation of CR or stable PR (i.e., no further tumor shrinkage).

Patients are followed at 4 weeks and then every 3 months thereafter.

PROJECTED ACCRUAL: A total of 15-30 patients will be accrued for this study within 12-18 months.

Study Design

• Study Type: Interventional
• Actual Enrollment: 18 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase II Study Of Perifosine (D-21266) In Previously Untreated Patients With Metastatic Or Recurrent Malignant Melanoma
• Actual Study Start Date: May 16, 2003
• Actual Primary Completion Date: Sep 14, 2004
• Actual Study Completion Date: Dec 21, 2009

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 120 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tom Baker Cancer Center - Calgary	Calgary	Alberta	Canada	T2N 4N2
2	Nova Scotia Cancer Centre	Halifax	Nova Scotia	Canada	B3H 1V7
3	Cancer Care Ontario-London Regional Cancer Centre	London	Ontario	Canada	N6A 4L6
4	Princess Margaret Hospital at University Health Network	Toronto	Ontario	Canada	M5G 2M9
5	Centre Hospitalier de l'Universite de Montreal	Montreal	Quebec	Canada	H2L-4M1
6	McGill University	Montreal	Quebec	Canada	H2W 1S6

Sponsors and Collaborators

• NCIC Clinical Trials Group
• National Cancer Institute (NCI)

Investigators

• Study Chair: Donald S. Ernst, MD, FRCPC, London Health Sciences Centre

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: NCIC Clinical Trials Group
• ClinicalTrials.gov Identifier: NCT00053781
• Other Study ID Numbers: I156; CAN-NCIC-IND156; CDR0000269475
• First Posted: Feb 6, 2003
• Last Update Posted: Apr 8, 2020
• Last Verified: Apr 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes
• Keywords provided by NCIC Clinical Trials Group: recurrent melanoma; stage IV melanoma
• Additional relevant MeSH terms: Melanoma

Study Results

No Results Posted as of Apr 8, 2020