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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01212276
Other study ID # MORAb-028-001
Secondary ID
Status Terminated
Phase Phase 1
First received September 29, 2010
Last updated July 15, 2014
Start date December 2010
Est. completion date September 2012

Study information

Verified date July 2014
Source Morphotek
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate whether therapy with MORAb-028 is safe, effective, and to determine the appropriate dose of MORAb-028 in the treatment of metastatic melanoma.


Description:

Melanoma is a serious form of skin cancer. If untreated, the melanoma can spread beyond the original affected tissue and invade distant tissue and organs. Treatment for metastatic melanoma includes medical treatments (chemotherapy or immunotherapy), surgery, or radiation therapy. MORAb-028 is a recombinant human immunoglobulin M (IgM) monoclonal antibody that recognizes a cell surface diacyl ganglioside named disialoganglioside (GD2). GD2 is overexpressed in tumors of neuro-ectodermal origin such as melanomas, neuroblastomas, small-cell lung carcinomas, and many sarcomas, while absent in most normal tissues. GD2 expression has been demonstrated in human melanoma and small cell lung cancer by thin layer chromatography and radiolabeled anti-GD2 antibody detection. It is hypothesized that one mode of action of MORAb-028 is complement-dependent cytotoxicity. Complement-dependent cytotoxicity is a mechanism for killing tumor cells in which an antibody bound to the target cell surface fixes complement, which results in assembly of the complement membrane attack complex that punches holes in the target cell membrane resulting in subsequent cell lysis. IgMs strongly bind to C1Q and robustly activate complement-dependent cytotoxicity. MORAb-028 is being developed as a potential therapy for GD2-positive tumors.


Recruitment information / eligibility

Status Terminated
Enrollment 18
Est. completion date September 2012
Est. primary completion date June 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Measurable metastatic melanoma that has failed standard therapy

- Males and females greater than or equal to 18 years of age

- Life expectancy of greater than or equal to 3 months

Exclusion Criteria:

- Significant cardiovascular impairment

- Clinically significant illness, medical condition, surgical history, or laboratory abnormality that could affect the safety of the subject or negatively impact the study results

- Chemotherapy, radiotherapy, or immunotherapy within 3 weeks prior to administration to MORAb-028

Study Design

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


Intervention

Drug:
MORAb-028
Cohort 1: 0.1 mg/kg IV on study day 1 only Cohort 2: 0.2 mg/kg IV on study day 1 only Cohort 3: 0.5 mg/kg IV on study day 1 only Cohort 4: 1.0 mg/kg IV on study day 1 only

Locations

Country Name City State
United States Memorial Sloan-Kettering Cancer Center New York New York

Sponsors (1)

Lead Sponsor Collaborator
Morphotek

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Safety of single dose radio labeled MORAb-028 in subjects with metastatic melanoma Daily for 7 days followed by weekly for 2 weeks, then biweekly for 4 weeks Yes
Secondary Radiologic distribution of a single i.v. infusion of MORAb-028 Daily for 1 week post study drug administration Yes
Secondary Pharmacokinetic parameters of labeled and unlabeled MORAb-028 Daily for 7 days followed by weekly for 2 weeks, then biweekly for 4 weeks Yes
Secondary The incidence of human antihuman antibody formation Week 2 and Week 8 Yes
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