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A Phase I/II Study of High-Dose Calcitriol in Combination With Temozolomide for Patients With Metastatic Melanoma


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Metastatic Melanoma

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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 UniversityChicago, Illinois  60611