Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Calcitriol and Temozolomide in Treating Patients With Metastatic Melanoma

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II, Phase I	Treatment	Active	18 and over	NCI, Pharmaceutical / Industry	NU-05M1 NU-0310-093, SPRI-NU-05M1, NCT00301067

Objectives

Primary

1. Determine the maximum tolerate dose of high-dose calcitriol when administered with temozolomide in patients with metastatic melanoma.
2. Assess toxicity of seven-day on/seven-day off temozolomide in combination with high-dose calcitriol.

Secondary

1. Determine tumor response and time to progression.
2. Investigate the relationship between vitamin D-receptor gene polymorphisms and tumor response.

Entry Criteria

Disease Characteristics:

• 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
  • Patients with no prior systemic therapy are eligible provided they are not candidates for high-dose interleukin-2

Prior/Concurrent Therapy:

• See Disease Characteristics
• Recovered from all toxic effects of prior therapy
• More than 4 weeks since prior and no concurrent radiotherapy, chemotherapy, or immunotherapy
• No prior temozolomide or dacarbazine
• No investigational agent within 4 weeks prior to study entry
• No concurrent magnesium-containing antacids, digitalis, bile-resin binding drugs, or calcium supplements

Patient Characteristics:

• ECOG performance status 0, 1, or 2
• Creatinine < 2 mg/dL OR creatinine clearance > 50 mL/min
• Calcium < 10.5 mg/dL
• Phosphorus < 4.3 mg/dL
• Bilirubin normal
• Platelet count > 100,000/mm³
• WBC > 3,500/mm³
• Life expectancy ≥ 4 months
• No known HIV positivity
• No evidence of active infection requiring antibiotic therapy
• No other malignancy within the past 5 years except surgically resected basal cell or squamous cell skin cancer
• No significant medical disease which, in the opinion of the investigator, may interfere with study completion
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception

Expected Enrollment

A total of 28 patients will be accrued for this study.

Outcomes

Safety and tolerability

Tumor response
Time to progression

Outline

This is a dose-escalation study of calcitriol followed by a phase II study.

• 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 Contact Information

Trial Lead Organizations

Robert H. Lurie Comprehensive Cancer Center at Northwestern University

Timothy Kuzel, MD, Protocol chair		Ph: 312-695-6180
John Eklund, MD, Protocol co-chair		Ph: 312-695-6180 Email: j-eklund@northwestern.edu

U.S.A.
Illinois
	Chicago
	Robert H. Lurie Comprehensive Cancer Center at Northwestern University
		Clinical Trials Office - Robert H. Lurie Comprehensive Cancer Center at Northwestern University	Ph:  312-695-1301
			Email: cancer@northwestern.edu

Registry Information
Official Title		A Phase I/II Study of High-Dose Calcitriol in Combination with Temozolomide for Patients with Metastatic Melanoma
Trial Start Date		2005-11-17
Trial Completion Date		2011-11-30 (estimated)
Registered in ClinicalTrials.gov		NCT00301067
Date Submitted to PDQ		2005-10-20
Information Last Verified		2009-07-05
NCI Grant/Contract Number		CA60553

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