Status:
COMPLETED
Phase I/II Study of High-Dose Calcitriol Plus Temodar for Patients With Metastatic Melanoma
Lead Sponsor:
Northwestern University
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Metastatic Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Calcitriol may hel...
Detailed Description
\* Phase I: Patients receive oral calcitriol on days 1 and 15 and oral temozolomide on days 2-8 and 16-22. Treatment repeats every 28 days for 2 courses in the absence of unacceptable toxicity. Respon...
Eligibility Criteria
Inclusion
- Histologically confirmed malignant melanoma
- Any primary tumor site
- Stage IV disease
- CNS metastases allowed
- Measurable disease, defined as at least 1 lesion that can be accurately measured in at least 1 dimension as ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
- Must have had at least 1 prior systemic therapy
- Negative pregnancy test
- Fertile patients must use effective contraception
- Patients with no prior systemic therapy are eligible provided they are not candidates for high-dose interleukin-2
- Recovered from all toxic effects of prior therapy
- More than 4 weeks since prior and no concurrent radiotherapy, chemotherapy, or immunotherapy
- More than 4 weeks since prior and no concurrent radiotherapy, chemotherapy, or immunotherapy
- Fertile patients must use effective contraception
Exclusion
- Life expectancy less than 4 months
- known HIV positivity
- evidence of active infection requiring antibiotic therapy
- other malignancy within the past 5 years except surgically resected basal cell or squamous cell skin cancer
- significant medical disease which, in the opinion of the investigator, may interfere with study completion
- pregnant or nursing
- Negative pregnancy test
- prior temozolomide or dacarbazine
- investigational agent within 4 weeks prior to study entry
- concurrent magnesium-containing antacids, digitalis, bile-resin binding drugs, or calcium supplements
Key Trial Info
Start Date :
January 30 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 9 2012
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00301067
Start Date
January 30 2005
End Date
July 9 2012
Last Update
June 4 2019
Active Locations (1)
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1
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States, 60611-3013