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A Phase 1 Clinical Trial of Intra-Tumoral Injection of Human IgM Monoclonal Antibody (MORAb-028) to the Ganglioside GD2 in Subjects With Injectable Metastatic Melanoma


Phase 1
18 Years
N/A
Not Enrolling
Both
Melanoma

Thank you

Trial Information

A Phase 1 Clinical Trial of Intra-Tumoral Injection of Human IgM Monoclonal Antibody (MORAb-028) to the Ganglioside GD2 in Subjects With Injectable Metastatic Melanoma


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety of multiple intralesional administration of MORAb-028

Outcome Description:

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)

Outcome Time Frame:

Day 33

Safety Issue:

Yes

Principal Investigator

Bruce Wallin, MD

Investigator Role:

Study Director

Investigator Affiliation:

Morphotek

Authority:

United States: Food and Drug Administration

Study ID:

MORAb028-002

NCT ID:

NCT01123304

Start Date:

May 2010

Completion Date:

March 2012

Related Keywords:

  • Melanoma
  • melanoma
  • Melanoma

Name

Location
John Wayne Cancer Institute Santa Monica, California  90404