A Phase I/II Study of High-Dose Calcitriol in Combination With Temozolomide for Patients With Metastatic Melanoma
18 Years
N/A
Both
Metastatic Melanoma
Trial Information
A Phase I/II Study of High-Dose Calcitriol in Combination With Temozolomide for Patients With Metastatic Melanoma
* 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.
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Maximum tolerated dose of high-dose calcitriol
Outcome Description:
Determine the maximum tolerate dose of high-dose calcitriol when administered with temozolomide in patients with metastatic melanoma for up to 12 months
Outcome Time Frame:
Up to 12 months
Safety Issue:
Yes
Principal Investigator
Timothy M. Kuzel, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Robert H. Lurie Cancer Center
Authority:
United States: Food and Drug Administration
Study ID:
NU 05M1
NCT ID:
NCT00301067
Start Date:
May 2005
Completion Date:
May 2015
Related Keywords:
- Metastatic Melanoma
- stage IV melanoma
- recurrent melanoma
- Melanoma
Name | Location |
|---|---|
| Robert H. Lurie Comprehensive Cancer Center at Northwestern University | Chicago, Illinois 60611 |
