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Calcitriol Plus Carboplatin in Treating Patients With Advanced Solid Tumors

NCT ID: NCT00008086

Last Updated: 2013-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

1996-01-31

Study Completion Date

2004-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Brain and Central Nervous System Tumors Unspecified Adult Solid Tumor, Protocol Specific

Keywords

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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

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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calcitriol

Intervention Type DIETARY_SUPPLEMENT

carboplatin

Intervention Type DRUG

Eligibility Criteria

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Inclusion 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

University of Pittsburgh

OTHER

Sponsor Role lead

Responsible Party

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Laura A. Pollice

Clinical Research Manager

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ramesh K. Ramanathan, MD

Role: STUDY_CHAIR

University of Pittsburgh

Locations

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University of Pittsburgh Cancer Institute

Pittsburgh, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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CDR0000068374

Identifier Type: REGISTRY

Identifier Source: secondary_id

PCI-IRB-970532

Identifier Type: -

Identifier Source: secondary_id

NCI-G00-1885

Identifier Type: -

Identifier Source: secondary_id

97-004

Identifier Type: -

Identifier Source: org_study_id