Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Calcitriol and Temozolomide in Treating Patients With Metastatic Melanoma
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), January 2009
Sponsors and Collaborators: Robert H. Lurie Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00301067
  Purpose

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.


Condition Intervention Phase
Intraocular Melanoma
Melanoma (Skin)
Drug: calcitriol
Drug: temozolomide
Phase I
Phase II

Genetics Home Reference related topics: retinoblastoma
MedlinePlus related topics: Cancer Melanoma
Drug Information available for: Temozolomide Calcitriol
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment
Official Title: A Phase I/II Study of High-Dose Calcitriol in Combination With Temozolomide for Patients With Metastatic Melanoma

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Safety and tolerability [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Tumor response [ Designated as safety issue: No ]
  • Time to progression [ Designated as safety issue: No ]

Estimated Enrollment: 28
Study Start Date: November 2005
Estimated Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

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

Secondary

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

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.

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

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/mm^3
  • WBC > 3,500/mm^3
  • 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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00301067

Locations
United States, Illinois
Robert H. Lurie Comprehensive Cancer Center at Northwestern University Recruiting
Chicago, Illinois, United States, 60611-3013
Contact: Clinical Trials Office - Robert H. Lurie Comprehensive Cancer     312-695-1301     cancer@northwestern.edu    
Sponsors and Collaborators
Robert H. Lurie Cancer Center
Investigators
Study Chair: Timothy M. Kuzel, MD Robert H. Lurie Cancer Center
Investigator: John Eklund, MD Robert H. Lurie Cancer Center
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Responsible Party: Robert H. Lurie Comprehensive Cancer Center at Northwestern University ( Timothy M. Kuzel )
Study ID Numbers: CDR0000456777, NU-05M1, NU-0310-093, SPRI-NU-05M1
Study First Received: March 8, 2006
Last Updated: January 9, 2009
ClinicalTrials.gov Identifier: NCT00301067  
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
stage IV melanoma
recurrent melanoma
intraocular melanoma
recurrent intraocular melanoma

Study placed in the following topic categories:
Eye Neoplasms
Eye Diseases
Temozolomide
Recurrence
Melanoma
Neuroendocrine Tumors
Calcitriol
Calcium, Dietary
Neuroectodermal Tumors
Uveal melanoma
Neoplasms, Germ Cell and Embryonal
Nevus, Pigmented
Intraocular melanoma
Neuroepithelioma
Nevus

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Growth Substances
Neoplasms, Nerve Tissue
Physiological Effects of Drugs
Calcium Channel Agonists
Bone Density Conservation Agents
Cardiovascular Agents
Pharmacologic Actions
Membrane Transport Modulators
Neoplasms
Neoplasms by Site
Therapeutic Uses
Vitamins
Vasoconstrictor Agents
Nevi and Melanomas
Antineoplastic Agents, Alkylating
Micronutrients
Alkylating Agents

ClinicalTrials.gov processed this record on January 15, 2009