This trial is active, not recruiting.

Condition metastatic melanoma
Treatments calcitriol, temozolomide
Phase phase 1/phase 2
Sponsor Northwestern University
Collaborator National Cancer Institute (NCI)
Start date May 2005
End date May 2016
Trial size 28 participants
Trial identifier NCT00301067, NU 05M1, NU-0310-093, NU-05M1, P30CA060553, SPRI-NU-05M1


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 help temozolomide kill more tumor cells by making them more sensitive to the drug. Calcitriol may also stop the growth of melanoma by blocking blood flow to the tumor.

PURPOSE: This phase I/II trial is studying the best dose of calcitriol, the side effects of calcitriol when given together with temozolomide, and to see how well they work in treating patients with metastatic stage IV melanoma.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
The patient will receive calcitriol in capsule form by mouth on Days 1 and 15 of every cycle
The patient will receive temozolomide in capsule form by mouth on Days 2-8 and 16-22 of each 28 study treatment cycle

Primary Outcomes

Maximum tolerated dose of high-dose calcitriol
time frame: Up to 12 months
Assess toxicity
time frame: Every 2 weeks for up to 12 months

Secondary Outcomes

Tumor response and time to progression
time frame: every 8 weeks for up to 12 months
The relationship between vitamin D-receptor gene polymorphisms and tumor response
time frame: Prestudy and at disease progression or when patient goes off study

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - 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 Criteria: - 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

Additional Information

Official title A Phase I/II Study of High-Dose Calcitriol in Combination With Temozolomide for Patients With Metastatic Melanoma
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. Responding patients continue therapy for up to 6 courses in the absence of unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of calcitriol until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity. - Phase II: Patients receive temozolomide and calcitriol at the MTD as in phase I. After completion of study treatment, patients are followed every 3 months.
Trial information was received from ClinicalTrials.gov and was last updated in September 2015.
Information provided to ClinicalTrials.gov by Northwestern University.