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Phase I/II Study of High-Dose Calcitriol Plus Temodar for Patients With Metastatic Melanoma

This study is ongoing, but not recruiting participants.
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Northwestern University Identifier:
First received: March 8, 2006
Last updated: November 16, 2016
Last verified: November 2016

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
Metastatic Melanoma
Dietary Supplement: calcitriol
Drug: temozolomide
Phase 1
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I/II Study of High-Dose Calcitriol in Combination With Temozolomide for Patients With Metastatic Melanoma

Resource links provided by NLM:

Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • Maximum tolerated dose of high-dose calcitriol [ Time Frame: Up to 12 months ]
    Determine the maximum tolerate dose of high-dose calcitriol when administered with temozolomide in patients with metastatic melanoma for up to 12 months

  • Assess toxicity [ Time Frame: Every 2 weeks for up to 12 months ]
    Assess toxicity of seven-day on/seven-day off temozolomide in combination with high-dose calcitriol for every 2 weeks for up to 12 months

Secondary Outcome Measures:
  • Tumor response and time to progression [ Time Frame: every 8 weeks for up to 12 months ]
    Determine tumor response and time to progression 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 ]
    Investigate the relationship between vitamin D-receptor gene polymorphisms and tumor response at prestudy and at disease progression, or when patient goes off study.

Estimated Enrollment: 28
Study Start Date: May 2005
Estimated Study Completion Date: May 2019
Estimated Primary Completion Date: May 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: temozolomide Dietary Supplement: calcitriol
The patient will receive calcitriol in capsule form by mouth on Days 1 and 15 of every cycle
Drug: temozolomide
The patient will receive temozolomide in capsule form by mouth on Days 2-8 and 16-22 of each 28 study treatment cycle

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. 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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

United States, Illinois
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States, 60611-3013
Sponsors and Collaborators
Northwestern University
National Cancer Institute (NCI)
Study Chair: Timothy M. Kuzel, MD Robert H. Lurie Cancer Center
  More Information

Responsible Party: Northwestern University Identifier: NCT00301067     History of Changes
Other Study ID Numbers: NU 05M1
P30CA060553 ( US NIH Grant/Contract Award Number )
Study First Received: March 8, 2006
Last Updated: November 16, 2016

Keywords provided by Northwestern University:
stage IV melanoma
recurrent melanoma

Additional relevant MeSH terms:
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Calcium Channel Agonists
Membrane Transport Modulators
Vasoconstrictor Agents
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents processed this record on April 28, 2017