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Sponsors and Collaborators: |
UPMC Cancer Centers National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00008086 |
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Calcitriol may help solid tumor cells develop into normal cells. Combining calcitriol with chemotherapy may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of calcitriol combined with carboplatin in treating patients who have advanced solid tumors.
Condition | Intervention | Phase |
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Brain and Central Nervous System Tumors Unspecified Adult Solid Tumor, Protocol Specific |
Drug: calcitriol Drug: carboplatin |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase I Trial of Subcutaneous And/Or Oral Calcitriol [(1,25-COH)2D3] and Carboplatin in Advanced Solid Tumors |
Study Start Date: | January 1996 |
OBJECTIVES:
OUTLINE: This is a dose-escalation study. Patients are stratified according to disease (brain tumor vs other solid tumor) and accrued in parallel. Patients are assigned to one of two treatment groups.
In both groups, treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Sequential dose escalation of calcitriol is followed by sequential dose escalation of carboplatin. Cohorts of 3-6 patients receive escalating doses of calcitriol and then carboplatin until the maximum tolerated dose (MTD) of the combination is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.
PROJECTED ACCRUAL: Approximately 18-50 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
United States, Pennsylvania | |
University of Pittsburgh Cancer Institute | |
Pittsburgh, Pennsylvania, United States, 15213-3489 |
Study Chair: | Ramesh K. Ramanathan, MD | UPMC Cancer Centers |
Study ID Numbers: | CDR0000068374, PCI-97-004, PCI-IRB-970532, NCI-G00-1885 |
Study First Received: | January 6, 2001 |
Last Updated: | November 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00008086 |
Health Authority: | United States: Federal Government |
recurrent adult brain tumor adult brain stem glioma adult craniopharyngioma adult medulloblastoma adult meningioma adult glioblastoma unspecified adult solid tumor, protocol specific adult anaplastic astrocytoma adult myxopapillary ependymoma adult anaplastic ependymoma adult anaplastic oligodendroglioma adult mixed glioma |
adult central nervous system germ cell tumor adult pilocytic astrocytoma adult subependymoma adult ependymoblastoma adult pineocytoma adult pineoblastoma adult meningeal hemangiopericytoma adult choroid plexus tumor adult grade III meningioma adult oligodendroglioma adult giant cell glioblastoma adult gliosarcoma |
Choroid Plexus Neoplasms Glioblastoma Astrocytoma Carboplatin Central Nervous System Neoplasms Hemangiopericytoma Recurrence Ependymoma Calcitriol Calcium, Dietary |
Brain Neoplasms Craniopharyngioma Medulloblastoma Oligodendroglioma Meningioma Glioma Choroid Plexus neoplasms Gliosarcoma Pinealoma Nervous System Neoplasms |
Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Growth Substances Nervous System Diseases 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 Micronutrients |