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| Sponsors and Collaborators: |
University of Wisconsin, Madison National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00036790 |
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Motexafin gadolinium may increase the effectiveness of doxorubicin by making tumor cells more sensitive to the drug.
PURPOSE: Phase I trial to study the effectiveness of combining motexafin gadolinium with doxorubicin in treating patients who have recurrent or metastatic cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer Chronic Myeloproliferative Disorders Colorectal Cancer Head and Neck Cancer Leukemia Lung Cancer Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic/Myeloproliferative Diseases Prostate Cancer Small Intestine Cancer Unspecified Adult Solid Tumor, Protocol Specific |
Drug: doxorubicin hydrochloride Drug: motexafin gadolinium |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | An Open-Label Phase I Dose Escalation Trial To Evaluate The Safety And Pharmacokinetics Of Motexafin Gadolinium And Doxorubicin Chemotherapy In The Treatment Of Advanced Malignancies |
| Study Start Date: | February 2002 |
OBJECTIVES:
OUTLINE: This is a dose-escalation, multicenter study. Patients are assigned to 1 of 2 groups.
Group A:
Group B:
Treatment in both groups continues for up to 6 courses in the absence of disease progression, unacceptable toxicity, or a cumulative doxorubicin dose of 450 mg/m^2.
Cohorts of 3-6 patients receive escalating doses of doxorubicin and motexafin gadolinium until the maximum tolerated dose (MTD) is determined. The MTD is defined as the highest dose at which no more than 0 of 3 or 1 of 6 patients experience dose-limiting toxicity.
Patients are followed at 1 and 2 months.
PROJECTED ACCRUAL: A total of 3-48 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 |
DISEASE CHARACTERISTICS:
Histologically confirmed advanced malignancy that is considered incurable
Relapsed solid tumors include, but are not limited to the following sites:
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age:
Sex
Menopausal status
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations| United States, Pennsylvania | |
| Hillman Cancer Center at University of Pittsburgh Cancer Institute | |
| Pittsburgh, Pennsylvania, United States, 15232 | |
| United States, Wisconsin | |
| University of Wisconsin Comprehensive Cancer Center | |
| Madison, Wisconsin, United States, 53792 | |
| Study Chair: | Markus Renschler, MD | Pharmacyclics |
More Information
| Study ID Numbers: | CDR0000069322, WCCC-CO-01910, PCI-PCYC-0207, NCI-G02-2061 |
| Study First Received: | May 13, 2002 |
| Last Updated: | November 16, 2008 |
| ClinicalTrials.gov Identifier: | NCT00036790 |
| Health Authority: | United States: Federal Government |
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stage III adult Hodgkin lymphoma stage IV adult Hodgkin lymphoma recurrent adult Hodgkin lymphoma stage III cutaneous T-cell non-Hodgkin lymphoma stage IV cutaneous T-cell non-Hodgkin lymphoma recurrent cutaneous T-cell non-Hodgkin lymphoma isolated plasmacytoma of bone extramedullary plasmacytoma refractory multiple myeloma Waldenstrom macroglobulinemia stage III multiple myeloma stage III chronic lymphocytic leukemia stage IV chronic lymphocytic leukemia recurrent adult acute myeloid leukemia recurrent adult acute lymphoblastic leukemia |
relapsing chronic myelogenous leukemia refractory chronic lymphocytic leukemia small intestine lymphoma unspecified adult solid tumor, protocol specific chronic phase chronic myelogenous leukemia accelerated phase chronic myelogenous leukemia blastic phase chronic myelogenous leukemia meningeal chronic myelogenous leukemia untreated adult acute lymphoblastic leukemia untreated adult acute myeloid leukemia refractory hairy cell leukemia chronic myelomonocytic leukemia T-cell large granular lymphocyte leukemia acute undifferentiated leukemia stage III grade 1 follicular lymphoma |
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Thoracic Neoplasms Blast Crisis Sezary syndrome Prostatic Diseases Chronic myelogenous leukemia Hodgkin lymphoma, adult Lymphoma, small cleaved-cell, diffuse Urogenital Neoplasms Ileal Diseases Lymphoma, large-cell, immunoblastic Leukemia, Prolymphocytic Hemorrhagic Disorders Lung Neoplasms Metastatic squamous neck cancer with occult primary Oral cancer |
Lymphoma, Large-Cell, Anaplastic Neoplasm Metastasis Laryngeal carcinoma Non-small cell lung cancer Precursor Cell Lymphoblastic Leukemia-Lymphoma Hematologic Diseases Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative Leukemia, Myelomonocytic, Chronic Blood Coagulation Disorders Acute myelogenous leukemia Breast Neoplasms Leukemia, Myeloid Myelodysplastic myeloproliferative disease Waldenstrom Macroglobulinemia Plasmacytoma |
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Respiratory Tract Neoplasms Neoplasms by Histologic Type Immune System Diseases Antineoplastic Agents Physiological Effects of Drugs Antibiotics, Antineoplastic Pharmacologic Actions Neoplasms |
Photosensitizing Agents Neoplasms by Site Radiation-Sensitizing Agents Jejunal Diseases Therapeutic Uses Cardiovascular Diseases Dermatologic Agents |
