Rituximab in Metastatic Melanoma

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Medical University of Vienna

Status and phase

Terminated
Phase 1

Conditions

Metastatic Melanoma

Treatments

Drug: rituximab

Study type

Interventional

Funder types

Other

Identifiers

NCT01032122
MIMM1

Details and patient eligibility

About

The purpose of this study is to determine whether rituximab as an adjuvant therapy in clinical stage IIIc / IV (no evidence of disease, AJCC (American Joint Committee on Cancer) 2002) melanoma patients is safe and prolongs overall survival and disease-free interval.

Enrollment

9 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Histologically verified non-ocular melanoma stage IIIc/IV, no evidence of disease

Exclusion criteria

  • ECOG (Eastern Cooperative Oncology Group) performance status > 2
  • Ocular melanoma
  • Immunodeficiency syndromes or hypogammaglobulinaemia
  • Active autoimmune diseases
  • Treatment with immunosuppressive agents other than steroids
  • Depressed bone marrow function (Leukopenia <3000, platelet count <100.000)
  • Cardiac insufficiency NYHA (New York Heart Association) IV
  • active Hepatitis B,C, or HIV infection
  • Pregnancy or lactation
  • Interstitial pulmonary disease
  • Former treatment with anti-CD20 antibody

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

9 participants in 1 patient group

rituximab
Experimental group
Treatment:
Drug: rituximab

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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