# SPECIFIC ACTIVE IMMUNOTHERAPY OF HUMAN MELANOMA

> **NIH NIH R01** · UNIVERSITY OF SOUTHERN CALIFORNIA · 1989 · $169,812

## Abstract

We will continue to develop active specific immunotherapy for
melanoma, one version of which has caused regression in 30% of
patients in a Phase I trial, stimulating both cell-mediated
immunity and antibodies.  Four complementary approaches will be
taken:  1) optimization of the clinical regimen, 2)
characterization of the phenotype and targets of the cytolytic
lymphocytes elicited, 3) analysis of the targets of the serum
antibodies, and 4) characterization and purification of the
antigens identified by our series of human monoclonal antibodies.
First, Phase II trials will be performed to establish a true
response rate at the optimal dose determined in Phase I, and to
explore a schedule resembling an optimal immunization schema in
mice.  The clinical regimen will be improved mainly by the use of
enriched, more varied, and more purified sources of immunogens.
A Phase I trial with one lysate of particular interest will be
performed.  A Phase II trial of a "polyvalent" preparation derived
from several melanomas will then be conducted with melanoma cell
membranes, if they prove to be an enriched source of immunogens.
Finally, a large scale Phase III randomized trial will be conducted
to measure survival in patients with microscopical residua, with
the preparation found to be optimal by then.  We will monitor all
trails by immunological assays.  The frequency of cytolytic
lymphocytes will be measured biweekly by limiting dilution assays.
Antibodies will also be measured serially by enzyme immunoassay and
Western immunoblotting.  Skin tests with melanoma lysates and HLA-
matched controls will be done before and after treatment.  We will
characterize the cytolytic lymphocytes, which appear to be
nonclassical T cells, by cold target competition assays with
various tumors and normal cells.  Clones will be established to
best determine their identity and targets.  The role of HLA
determinants as targets or co-determinants in cytolysis will also
be explored.  Absorption analysis with enzyme immunoassay and
Western immunoblotting will be used to see which melanoma antigens
elicit serum antibodies, and to localize the antigens in the
melanoma cell.  Biochemical characterization of the antigens in
the interior of the melanoma cell that recognized by our human
monoclonal antibodies will be continued.  Recombinant DNA
technology will be used to clone the antigens, to study their
nature and to provide purified materials for future vaccines.

## Key facts

- **NIH application ID:** 3173746
- **Project number:** 5R01CA036233-06
- **Recipient organization:** UNIVERSITY OF SOUTHERN CALIFORNIA
- **SAM.gov UEI:** G88KLJR3KYT5
- **Principal Investigator:** Malcolm Stuart Mitchell
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 1989
- **Award amount:** $169,812
- **Award type:** 5
- **Project period:** 1988-03-01 → 1990-12-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/3173746

## Citation

> US National Institutes of Health, RePORTER application 3173746, SPECIFIC ACTIVE IMMUNOTHERAPY OF HUMAN MELANOMA (5R01CA036233-06). Retrieved via MORVS 2026-10-25 from https://api.morvs.ai/grant/nih/3173746. Licensed CC0.

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