Calcitriol Plus Carboplatin in Treating Patients With Advanced Solid Tumors
The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2002 by National Cancer Institute (NCI).
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
University of Pittsburgh
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00008086
First received: January 6, 2001
Last updated: December 26, 2009
Last verified: October 2002
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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 |
|---|---|---|
|
Brain and Central Nervous System Tumors Unspecified Adult Solid Tumor, Protocol Specific |
Dietary Supplement: calcitriol Drug: carboplatin |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | A Phase I Trial of Subcutaneous And/Or Oral Calcitriol [(1,25-COH)2D3] and Carboplatin in Advanced Solid Tumors |
Resource links provided by NLM:
Further study details as provided by National Cancer Institute (NCI):
| Study Start Date: | January 1996 |
OBJECTIVES:
- Determine the maximum tolerated doses of calcitriol and carboplatin, when given in combination, in patients with advanced solid tumors.
- Determine the toxic effects of this regimen in these patients.
- Determine the effect of calcitriol on the pharmacokinetics of carboplatin in these patients.
- Correlate the pharmacokinetics of carboplatin with the myelosuppression following this regimen in these patients.
- Determine the safety and efficacy of this regimen in patients with malignant glioma.
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.
- Group 1: Patients receive carboplatin IV over 20-30 minutes on day 1 and calcitriol subcutaneously (SC) or orally daily on days 2-4 for the first course only. For subsequent courses, patients receive calcitriol SC or orally daily on days 1-3 and carboplatin IV over 20-30 minutes on day 3.
- Group 2: Patients receive calcitriol SC or orally daily on days 1-3 and carboplatin IV over 20-30 minutes on day 3 for the first, third, and subsequent courses. For the second course only, patients receive carboplatin IV over 20-30 minutes on day 1 and calcitriol SC or orally daily on days 2-4.
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed advanced solid tumor that is not curable by standard therapy, including glioma and other brain tumors
- Brain metastases allowed following definitive radiotherapy
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- ECOG 0-2
Life expectancy:
- At least 8 weeks
Hematopoietic:
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
Hepatic:
- Bilirubin no greater than 1.5 mg/dL
- SGOT no greater than 4 times normal
Renal:
- Creatinine no greater than 1.5 mg/dL OR
- Creatinine clearance at least 60 mL/min
- Creatinine no greater than 2.0 mg/dL
- Calcium no greater than 10.5 mg/dL
Cardiovascular:
- No unstable angina
- No symptomatic coronary artery disease
Other:
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use 2 forms of barrier contraception AND 1 form of hormonal contraception for at least 1 week before, during, and for at least 2 weeks after study
- No active infection
- No other concurrent serious condition
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- At least 4 weeks since prior biologic therapy (regional or systemic)
Chemotherapy:
- At least 4 weeks since prior chemotherapy
Endocrine therapy:
- No concurrent glucocorticoids as antiemetics
- Concurrent exogenous glucocorticoids allowed for treatment of gliomas or other brain tumors
Radiotherapy:
- See Disease Characteristics
- At least 4 weeks since prior radiotherapy
Surgery:
- Not specified
Other:
- Dietary calcium intake of no more than 200-250 mg/day beginning 48 hours before each course and continuing for 7 days
- No concurrent dairy products, green leafy vegetables, molasses, baking powder, fortified cereals, and dry peas and beans
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00008086
Locations
| United States, Pennsylvania | |
| University of Pittsburgh Cancer Institute | |
| Pittsburgh, Pennsylvania, United States, 15213-3489 | |
Sponsors and Collaborators
University of Pittsburgh
Investigators
| Study Chair: | Ramesh K. Ramanathan, MD | University of Pittsburgh |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00008086 History of Changes |
| Other Study ID Numbers: | CDR0000068374, PCI-97-004, PCI-IRB-970532, NCI-G00-1885 |
| Study First Received: | January 6, 2001 |
| Last Updated: | December 26, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
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 |
Additional relevant MeSH terms:
|
Nervous System Neoplasms Central Nervous System Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Calcitriol Carboplatin Vitamins Micronutrients Growth Substances |
Physiological Effects of Drugs Pharmacologic Actions Bone Density Conservation Agents Calcium Channel Agonists Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Vasoconstrictor Agents Cardiovascular Agents Therapeutic Uses Antineoplastic Agents |
ClinicalTrials.gov processed this record on May 19, 2013