Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Northwestern University
With
National Cancer Institute (NCI)
\* 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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | Phase I/II Study of High-Dose Calcitriol Plus Temodar for Patients With Metastatic Melanoma
