Phase I Safety Study of the Drug MM-121 in Patients With Advanced Solid Tumors Resisting Ordinary Treatment
Summary
This study is a Phase 1 and pharmacologic open-labeled dose-escalation trial using a "3+3" design. Successive cohorts of three or more patients will be treated at escalating doses until a maximum tolerated dose is identified. The study will initially explore a dosing schedule every 7-days, which may be modified to longer intervals under certain circumstances. Once the maximum tolerated dose or recommended Phase 2 dose is identified, an Expansion Cohort will be enrolled at that dose to further characterize safety and to explore pharmacodynamic endpoints. It is anticipated 2-3 study sites will participate in this trial.
Study Design
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Advanced Solid Tumors
Intervention
MM-121
Location
Dana-Farber Cancer Institute
Boston
Massachusetts
United States
02115-6084
Status
Recruiting
Source
Merrimack Pharmaceuticals
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00734305
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Lomustine
An alkylating agent of value against both hematologic malignancies and solid tumors.
Technology, High-cost
Advanced technology that is costly, requires highly skilled personnel, and is unique in its particular application. Includes innovative, specialized medical/surgical procedures as well as advanced diagnostic and therapeutic equipment.
Brenner Tumor
A smooth, solid or cystic fibroepithelial (FIBROEPITHELIAL NEOPLASMS) tumor, usually found in the OVARIES but can also be found in the adnexal region and the KIDNEYS. It consists of a fibrous stroma with nests of epithelial cells that sometimes resemble the transitional cells lining the urinary bladder. Brenner tumors generally are benign and asymptomatic. Malignant Brenner tumors have been reported.
Lymphoma, Aids-related
B-cell lymphoid tumors that occur in association with AIDS. Patients often present with an advanced stage of disease and highly malignant subtypes including BURKITT LYMPHOMA; IMMUNOBLASTIC LARGE-CELL LYMPHOMA; PRIMARY EFFUSION LYMPHOMA; and DIFFUSE, LARGE B-CELL, LYMPHOMA. The tumors are often disseminated in unusual extranodal sites and chromosomal abnormalities are frequently present. It is likely that polyclonal B-cell lymphoproliferation in AIDS is a complex result of EBV infection, HIV antigenic stimulation, and T-cell-dependent HIV activation.
Bleomycin
A complex of related glycopeptide antibiotics from Streptomyces verticillus consisting of bleomycin A2 and B2. It inhibits DNA metabolism and is used as an antineoplastic, especially for solid tumors.
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