Autologous and Allogeneic Whole Cell Cancer Vaccine for Metastatic Tumors

NCT00722228 | Recruiting Phase 1

• 1 other identifier: 0359-08-HMO-CTIL
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This study is based on the finding that tumor cells that are grown in the laboratory can be modified in such a way that, when injected to the patient, they will stimulate his/her immune response. This approach will be evaluated in patients with melanoma and colorectal, gastric, ovarian, breast, lung and kidney epithelial cancer. Tumor cells grown in the laboratory will be modified to make them stimulatory to the immune system, irradiated to kill them, and injected to the patient eight times at two-week intervals. This protocol is expected to prolong survival of metastatic cancer patients.

Conditions

Colorectal Cancer; Ovarian Cancer; Gastric Cancer; Breast Cancer; Lung Cancer; Kidney Cancer; Melanoma

Study Arms (1)

Autologous or Allogeneic tumor cells

EXPERIMENTAL

Intervention: 5 vaccine doses, 3 weeks apart, injected subcutaneously.

Biological: Autologous or Allogeneic tumor cells

Interventions

Autologous or Allogeneic tumor cells BIOLOGICAL

Five vaccine doses, injected subcutaneously at 3-week intervals. Each dose is composed of irradiated and DNP-conjugated tumor cells.

Autologous or Allogeneic tumor cells

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• One of the following metastatic cancers: Melanoma, breast, ovary, colorectal, gastric, lung or kidney
• Above 18 years of age
• Failure of at least one chemotherapy protocol
• Clinical performance status of ECOG 0,1
• Absolute neutrophil count greater than 1000/mm3
• Serum ALT/AST less than three times the upper limit of normal
• Serum creatinine less than or equal to 1.6 mg/dl.
• Must be able to understand and sign the Informed Consent document

You may not qualify if:

• Below 18 years of age
• Women who are pregnant
• Life expectancy of less than three months

Sponsors & Collaborators

• Hadassah Medical Organization: lead

Study Sites (1)

Hadassah Medical Organization

Jerusalem, 91120, Israel

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms; Ovarian Neoplasms; Stomach Neoplasms; Breast Neoplasms; Lung Neoplasms; Kidney Neoplasms; Melanoma

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Stomach Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Urologic Neoplasms; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms

Central Study Contacts

Hani Steinberg, R.N. B.A.

CONTACT

: 00 972 50 7874292; hanis@hadassah.org.il

Tamar Peretz, MD

CONTACT

00 972 2 6777825; tamary@hadassah.org.il

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2008
• First Posted: July 25, 2008
• Study Start: July 1, 2008
• Primary Completion: March 1, 2025
• Study Completion (Estimated): January 1, 2027
• Last Updated: October 2, 2025

Record last verified: 2025-03

Locations

IL (1)