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A Phase II Study Of Perifosine (D-21266) In Previously Untreated Patients With Metastatic Or Recurrent Malignant Melanoma


Phase 2
18 Years
N/A
Not Enrolling
Both
Melanoma (Skin)

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Trial Information

A Phase II Study Of Perifosine (D-21266) In Previously Untreated Patients With Metastatic Or Recurrent Malignant Melanoma


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.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Donald S. Ernst, MD, FRCPC

Investigator Role:

Study Chair

Investigator Affiliation:

London Regional Cancer Program at London Health Sciences Centre

Authority:

United States: Federal Government

Study ID:

I156

NCT ID:

NCT00053781

Start Date:

June 2003

Completion Date:

December 2009

Related Keywords:

  • Melanoma (Skin)
  • recurrent melanoma
  • stage IV melanoma
  • Melanoma

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