Safety Study of Human IgM (MORAb-028) to Treat Metastatic Melanoma

Phase 1TerminatedNCT01123304

Morphotek18 enrolled

Overview

This research is being done to find out the safety of MORAb-028 in subjects with metastatic melanoma.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Melanoma

Interventions

MORAb028DRUG

1 mg MORAb-028 will be injected at either 1 mg/cm3 per day over 5 days for a total dose of 5 mg for the first cohort and 2 mg/cm3 for the second cohort. Subjects will receive MORAb-028 injections on Days: 1-5, 8-12 and 22-26.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Histologically confirmed AJCC Stage IIIB, IIIC or IV melanoma with injectable metastases (in transit, intradermal, or subcutaneous nodules) * Tumor accessible to intra-tumoral injections * Cumulative tumor volume great enough to accept MORAb-028 injections for a given dose level, based on intent to inject at a concentration of 1 mg/cm3 Exclusion Criteria: * Are candidates for curative surgical excision or lymphadenectomy * Prior non-surgical treatment within 4 weeks * Known central nervous system (CNS) tumor involvement or metastases * Hypersensitivity to MORAb-028

Locations (1)

John Wayne Cancer Institute

Santa Monica, California, United States

Outcomes

Primary Outcomes

Safety of multiple intralesional administration of MORAb-028

After each patient completes study treatment the patient is evaluated for dose limiting toxicities (DLTs) up to 1 week after their last dose (at day 33)

Time frame: Day 33

Secondary Outcomes

Maximum tolerated dose of intralesional administration of MORAb-028

Time frame: 22 months

Data from ClinicalTrials.gov

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