Know Cancer

or
forgot password

Phase II Study of the Predictive Value of the Expression of Tumoral MGMT With Respect to the Therapeutic Response of Fotemustine in Patients With Metastatic Malignant Melanoma


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

Thank you

Trial Information

Phase II Study of the Predictive Value of the Expression of Tumoral MGMT With Respect to the Therapeutic Response of Fotemustine in Patients With Metastatic Malignant Melanoma


OBJECTIVES:

Primary

- Assess the relationship between MGMT expression and response to fotemustine in patients
with metastatic malignant melanoma.

Secondary

- Establish a value for MGMT expression below which fotemustine has a strong probability
of effectiveness.

OUTLINE: This is a multicenter study.

Patients receive induction chemotherapy comprising fotemustine IV over 1 hour on days 1, 8,
and 15. Beginning 5 weeks later, patients achieving stable or objective response receive
maintenance chemotherapy comprising fotemustine IV over 1 hour once every 3 weeks for 6
courses.

Tissue samples are collected at baseline to assess level of MGMT expression by PCR.

After completion of study treatment, patients are followed every 2 months.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed metastatic malignant melanoma, meeting the following
criteria:

- Metastatic lymph nodes or skin allowing for surgical resection

- At least 1 metastatic lesion (lymph nodes, skin, visceral, brain)

- Measurable or evaluable disease

PATIENT CHARACTERISTICS:

- WHO performance status 0-2

- ANC > 2 x 10^9/L

- Platelet count > 100 x 10^9/L

- Transaminases ≤ 2.5 times normal

- Alkaline phosphate ≤ 2.5 times normal

- Total bilirubin normal

- Not pregnant or nursing

- Fertile patients must use effective contraception

- No severe uncontrolled infection

- No other prior or concurrent malignancy (except basal cell or squamous cell carcinoma
in situ of the cervix that was curatively treated)

PRIOR CONCURRENT THERAPY:

- No prior chemotherapy

- At least 2 weeks since prior adjuvant therapy

- At least 4 weeks since prior radiotherapy

- At least 30 days since prior participation in another clinical trial

- No prior or concurrent prophylactic phenytoin

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Primary Purpose: Treatment

Outcome Measure:

Relationship between MGMT expression and response to fotemustine

Safety Issue:

No

Principal Investigator

Didier Cupissol, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Centre Val d'Aurelle - Paul Lamarque

Authority:

United States: Federal Government

Study ID:

CDR0000574147

NCT ID:

NCT00560118

Start Date:

August 2003

Completion Date:

Related Keywords:

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

Name

Location