Status:
COMPLETED
Study of the Combination of Lenalidomide and DTIC (Dacarbazine) in Patients With Metastatic Malignant Melanoma Previously Untreated With Systemic Chemotherapy
Lead Sponsor:
Celgene
Collaborating Sponsors:
Prologue Research International
Conditions:
Malignant Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This study will determine the MDT of intravenous DTIC when administered in combination with a fixed dose of oral lenalidomide in subjects with metastatic malignant melanoma previously untreated with s...
Eligibility Criteria
Inclusion
- Understand and voluntarily sign an informed consent document
- Age greater than or equal to 18 years at the time of signing Informed Consent
- Be able to adhere to the study visit schedule and other protocol requirements
- Histological documentation of malignant melanoma with evidence of metastatic disease
- For the 10 patients enrolled at the MTD, at least one measurable lesion must be present (see Appendix II)
- ECOG performance status of 0, 1 or 2 (see Appendix I)
- Laboratory tests within these ranges:
- Absolute neutrophil count greater than or equal to 1,500/uL
- Platelet count greater than or equal to 100,000/uL
- Serum creatinine less than or equal to 1.5 mg/dL
- Total bilirubin less that or equal to 1.5 mg.dL
- AST (SGOT) / ALT (SGPT) less than or equal to to 2 times upper limit of normal (ULN)
- Women of childbearing potential (WCBP) must have a negative serum or urine pregnancy test within 7 days of starting study drug.
- In addition, sexually active WCBP must agree to use at least two methods of adequate contraceptive (oral, injectable, or implantable hormonal contraceptive, tubal ligation, intra-uterine device, barrier contraceptive with spermicide, contraceptive skin patch or vasectomized partner) while on study drug
- All acute adverse effects (excluding alopecia of any prior therapy must have resolved to less than or equal to grade 1 (NCI CTCAE v3.0)
- Patients must be able to take medications orally
Exclusion
- Pregnant or lactating females
- Any serious medical condition, including psychiatric illnesses that will prevent the patient from signing the informed consent or place the patient at an unacceptable risk if he/she participates in the study.
- Prior treatment with systemic chemotherapy. Patients who have received prior immunotherapy, including thalidomide, or radiotherapy remain eligible.
- Lesions within a prior field of radiation may only be used as indicator lesions if there has been evidence of disease progression at that site.
- Prior history of malignancies (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast) unless the patient has been free of the disease for at least 3 years.
- Use of thalidomide or biologic response modifier therapy within 14 days of Day 1, Cycle 1
- Prior greater than or equal to grade 2 allergic reaction to thalidomide
- Prior desquamating rash while taking thalidomide
- Any prior use of lenalidomide
- Concurrent use of any other anti-cancer agents
- Radiation or surgical treatment of melanoma within 28 days of starting study treatment
- Active infection
- Central nervous system (CNS) metastases
- Patients with \> grade-2 neuropathy
- Patients with known HIV positivity or AIDS-related illness
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
End Date :
June 1 2007
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT00179608
Start Date
September 1 2005
End Date
June 1 2007
Last Update
November 8 2019
Active Locations (1)
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1
MD Anderson Cancer Center
Houston, Texas, United States, 77030-4009