Amrubicin + Cyclophosphamide in Advanced Solid Organ Malignancies

• Status: Completed
• Trial end date: 2010-07-01
• Target enrollment: 0
• Participant gender: All

Summary

Amrubicin has shown single-agent activity in lung cancer. The combination of cyclophosphamide and anthracyclines has been studied and concluded that the combination was tolerable, could be given safely, and therapeutically useful.

This Phase I study will evaluate the combination of cyclophosphamide with amrubicin in relapsed solid tumors and will define the MTD of the combination in a US population.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lawrence Einhorn
• Collaborators: Celgene Corporation; Hoosier Cancer Research Network
• Treatments: Amrubicin; Cyclophosphamide

Criteria

Inclusion Criteria:

• Histologically or cytologically confirmed advanced solid organ malignancy that is refractory to currently available therapies or for which no effective therapy exists.

• Must have measurable or evaluable disease per RECIST as evaluated by imaging within 30 days prior to registration for protocol therapy.

• Must have completed chemotherapy at least 28 days prior to registration for protocol therapy and recovered from the acute toxic effects.

• Prior radiation therapy is allowed to < 25% of the bone marrow. Patients must have recovered from the acute toxic effects of radiation prior to registration for protocol therapy.

• Must be willing to consent to the blood sample collection for SNP analysis.

• Females of childbearing potential and males must be willing to use an effective method of contraception (hormonal or barrier method of birth control; abstinence) from the time of consent until at least 30 days following completion of protocol therapy.

• Females of childbearing potential must have a negative pregnancy test within 7 days prior to registration for protocol therapy. Patients are considered not of child bearing potential if they are surgically sterile (they have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are postmenopausal.

• Written informed consent and HIPAA authorization for release of personal health information.

• Age > 18 years.

Exclusion Criteria:

• No prior therapy with cyclophosphamide or anthracyclines.

• No treatment with any investigational agent within 28 days prior to registration for protocol therapy.

• No suspected, diffuse idiopathic interstitial lung disease or history of pulmonary fibrosis.

• No evidence of severe or uncontrolled other systemic disease or any concurrent condition which in the investigator's opinion makes it undesirable for the patient to participate in the trial or which would jeopardize compliance with the protocol.

• No symptomatic brain metastases. Patients with treated brain metastasis must be off steroids and must have completed radiation at least 21 days prior to registration for protocol therapy.