Motexafin Gadolinium and Doxorubicin in Treating Patients With Advanced Cancer
Condition: 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
MeSH terms: Lymphoma; Breast Neoplasms; Leukemia; Lung Neoplasms; Prostatic Neoplasms; Multiple Myeloma; Neoplasms, Plasma Cell; Head and Neck Neoplasms; Plasmacytoma; Intestinal Neoplasms; Myeloproliferative Disorders; Myelodysplastic-Myeloproliferative Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      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.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the maximum tolerated dose of motexafin gadolinium and doxorubicin in patients
           with advanced malignancies.

        -  Determine the dose-limiting toxicity of this regimen in these patients.

        -  Determine the safety and tolerability of this regimen in these patients.

        -  Determine the pharmacokinetics of this regimen in these patients.

        -  Evaluate the tumor response in patients treated with this regimen.

      OUTLINE: This is a dose-escalation, multicenter study. Patients are assigned to 1 of 2
      groups.

      Group A:

        -  Course 1: Patients receive motexafin gadolinium IV over 30 minutes on days 1, 8, 9, and
           10 and doxorubicin IV over 15 minutes on day 8.

        -  Course 2: 28 days after the beginning of course 1, patients receive doxorubicin IV over
           15 minutes.

        -  Courses 3-6: Beginning 21 days after course 2, patients receive doxorubicin IV over 15
           minutes on day 1 and motexafin gadolinium IV over 30 minutes on days 1-3. Treatment
           repeats every 21 days.

      Group B:

        -  Course 1: Patients receive motexafin gadolinium IV over 30 minutes on day 1 and
           doxorubicin IV over 15 minutes on day 8.

        -  Course 2: 28 days after the beginning of course 1, patients receive doxorubicin IV over
           15 minutes on day 1 and motexafin gadolinium IV over 30 minutes on days 1-3.

        -  Courses 3-6: Beginning 21 days after course 2, patients receive doxorubicin and
           motexafin gadolinium as in group A.

      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.
    

Intervention name(s): doxorubicin hydrochloride; motexafin gadolinium
Intervention type(s): Drug; Drug
Intervention MeSH terms: Doxorubicin; Liposomal doxorubicin; Motexafin gadolinium
Primary purpose: Treatment
Keywords: 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; stage III grade 2 follicular lymphoma; stage III grade 3 follicular lymphoma; stage III adult diffuse small cleaved cell lymphoma; stage III adult diffuse mixed cell lymphoma; stage III adult diffuse large cell lymphoma; stage III adult immunoblastic large cell lymphoma; stage III adult lymphoblastic lymphoma; stage III adult Burkitt lymphoma; stage IV grade 1 follicular lymphoma; stage IV grade 2 follicular lymphoma; stage IV grade 3 follicular lymphoma; stage IV adult diffuse small cleaved cell lymphoma; stage IV adult diffuse mixed cell lymphoma; stage IV adult diffuse large cell lymphoma; stage IV adult immunoblastic large cell lymphoma; stage IV adult lymphoblastic lymphoma; stage IV adult Burkitt lymphoma; recurrent grade 1 follicular lymphoma; recurrent grade 2 follicular lymphoma; recurrent grade 3 follicular lymphoma; recurrent adult diffuse small cleaved cell lymphoma; recurrent adult diffuse mixed cell lymphoma; recurrent adult diffuse large cell lymphoma; recurrent adult immunoblastic large cell lymphoma; recurrent adult lymphoblastic lymphoma; recurrent adult Burkitt lymphoma; stage III adult T-cell leukemia/lymphoma; stage IV adult T-cell leukemia/lymphoma; recurrent adult T-cell leukemia/lymphoma; secondary acute myeloid leukemia; prolymphocytic leukemia; stage III mantle cell lymphoma; stage IV mantle cell lymphoma; recurrent mantle cell lymphoma; angioimmunoblastic T-cell lymphoma; anaplastic large cell lymphoma; stage III mycosis fungoides/Sezary syndrome; stage IV mycosis fungoides/Sezary syndrome; recurrent mycosis fungoides/Sezary syndrome; chronic eosinophilic leukemia; chronic neutrophilic leukemia; recurrent non-small cell lung cancer; recurrent small cell lung cancer; stage IIIA non-small cell lung cancer; stage IIIB non-small cell lung cancer; stage IV non-small cell lung cancer; extensive stage small cell lung cancer; limited stage small cell lung cancer; recurrent breast cancer; stage IIIA breast cancer; stage IIIB breast cancer; stage IIIC breast cancer; stage IV breast cancer; recurrent colon cancer; stage III colon cancer; stage IV colon cancer; recurrent prostate cancer; stage III prostate cancer; stage IV prostate cancer; recurrent lip and oral cavity cancer; stage III lip and oral cavity cancer; stage IV lip and oral cavity cancer; recurrent paranasal sinus and nasal cavity cancer; stage III paranasal sinus and nasal cavity cancer; stage IV paranasal sinus and nasal cavity cancer; recurrent metastatic squamous neck cancer with occult primary; recurrent hypopharyngeal cancer; stage III hypopharyngeal cancer; stage IV hypopharyngeal cancer; recurrent laryngeal cancer; stage III laryngeal cancer; stage IV laryngeal cancer; recurrent oropharyngeal cancer; stage III oropharyngeal cancer; stage IV oropharyngeal cancer; recurrent nasopharyngeal cancer; stage III nasopharyngeal cancer; stage IV nasopharyngeal cancer; atypical chronic myeloid leukemia; myelodysplastic/myeloproliferative disease, unclassifiable; recurrent marginal zone lymphoma; recurrent small lymphocytic lymphoma; stage III small lymphocytic lymphoma; stage III marginal zone lymphoma; stage IV small lymphocytic lymphoma; stage IV marginal zone lymphoma; extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue; nodal marginal zone B-cell lymphoma; splenic marginal zone lymphoma; adult acute myeloid leukemia with t(8;21)(q22;q22); adult acute myeloid leukemia with t(16;16)(p13;q22); adult acute myeloid leukemia with inv(16)(p13;q22); adult acute myeloid leukemia with 11q23 (MLL) abnormalities; adult acute myeloid leukemia with t(15;17)(q22;q12)