A Phase I Cancer Vaccine Study for Patients With Metastatic Breast Cancer

NCT00715832 | Unknown Phase 1 DMC

• 1 other identifier: QI-Breast Vaccine 1
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

The study uses a molecule or particle that is found only on cancer cells and is unique to cancer cells, as it is not detected on normal tissue. The molecule is known as "oncofetal antigen" or OFA. Because OFA is unique to cancer, the investigators feel OFA could be used to educate the patients' own defenses to more effectively fight the cancer on her own, he or she is harboring. Although investigators found OFA to be present in large concentrations on all cancers, it was found to be especially abundant in breast cancers. Therefore, the investigators feel that this molecule would be a good target for stimulating patient defenses especially against breast cancer cells. To accomplish this, certain defense cells (immune cells) will be washed out from the patients' blood using a machine to which the patient is connected through two small cannulas placed into veins located in the patients' arms. Those cells will be manipulated in the laboratory with artificially engineered OFA. These "reeducated" cells will be injected into the skin of patients. There will be a series of three skin injections in 4 week intervals. It is hoped that this treatment will convert the patients' defenses to a point that effective anti cancer responses will be induced. Effectiveness of the treatment will be monitored with blood tests and assessment of the size of the cancers.

Conditions

Metastatic Breast Cancer

Keywords

Breast cancer; Dendritic cell vaccine; OFA/iLRP; Patients; Line; Chemotherapy; Setting; Four different lines

Outcome Measures

Primary Outcomes (1)

• toxicity

  24 months

Secondary Outcomes (1)

• Response, Survival, Immunological Monitoring, Time to Disease Progression

  24 months

Interventions

Dendritic Cell Vaccination BIOLOGICAL

Autologous dendritic dells will be pulsed with human recombinant oncofetal antigen (OFP/iLRP). The vaccine will be injected intradermally

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Stage IV histologically proven breast cancer as defined by the AJCC Cancer Staging Manual (6 th. Edition 2003).
• Patients must have completed one prior form of chemo and/or radiation therapy for their disease and have failed to achieve remission.
• There must be no clinical or radiographic signs of active brain metastases (CT of brain), or disease to the brain that is not considered controlled.
• At least 4 weeks must have elapsed since chemotherapy or biological therapy and 2 weeks must have elapsed since radiotherapy
• Female patients must be at least 18 years of age
• Must be ambulatory with a ECOG performance status of \<2
• Must have common recall antigen DTH skin reaction \>2 mm
• Must have lab values as following ANC \> 1.5 x 109/L; platelets \> 100 x 109/L, Hb\> 9 g/dL, creatinine \< 1.8 mg/dL or a creatinine clearance \> 35 mL/min; total bilirubin \< 2 the upper limit of normal, AST and ALT \< 2.5 the upper limit of normal; albumin \>2.5 g/L
• If of child bearing potential, must practice a reliable method of contraception at screening and must agree to continue this status until 6 months after receiving the last study vaccine injection. An HCG (pregnancy) test will be done monthly until the 3 vaccinations are complete.
• Signed informed consent (see Appendix A, Clinical Protocol section 25.1) to be obtained according to ICH GCP guidelines before the patient is subjected to any extra diagnostic procedures performed for evaluation of eligibility for the trial.

You may not qualify if:

• History of other prior malignancy, with the exception of curatively treated basal cell or squamous cell carcinoma of the skin or cervical cancer stage IB
• Active infection requiring continuous use of antibiotic therapy
• Significant cardiac or other medical illness that would limit activity or survival, such as severe congestive heart failure, unstable angina, or serious cardiac arrhythmia
• Autoimmune disease currently treated with steroids
• Adverse reactions to vaccines such as anaphylaxis or other serious reactions, e.g. life-threatening reactions to medicine
• History of immunodeficiency or autoimmune disease such as rheumatoid arthritis,systemic lupus erythematosus, scleroderma, polymyositis dermatomyositis, juvenile onset, insulin dependent diabetes, or a vasculitic syndrome
• Pregnancy or lactation
• Any reason why, in the opinion of the investigator, the patient should not participate
• Patients who have received cytotoxic anti-tumor therapy within 4 weeks prior to vaccination
• Patients with active hepatitis (B, C) or HIV+ individuals
• Patients with more than four different lines of chemotherapy in the metastatic setting (excluding adjuvant chemotherapy).

Sponsors & Collaborators

• Southern Cancer Center: lead
• Quantum Immunologics, Inc.: collaborator
• University of South Alabama: collaborator

Study Sites (1)

Quantum Immunologics

Mobile, Alabama, 36606, United States

RECRUITING

Related Publications (17)

• Holtl L, Zelle-Rieser C, Gander H, Papesh C, Ramoner R, Bartsch G, Rogatsch H, Barsoum AL, Coggin JH Jr, Thurnher M. Immunotherapy of metastatic renal cell carcinoma with tumor lysate-pulsed autologous dendritic cells. Clin Cancer Res. 2002 Nov;8(11):3369-76.

  PMID: 12429623 BACKGROUND

• Rohrer JW, Barsoum AL, Dyess DL, Tucker JA, Coggin JH Jr. Human breast carcinoma patients develop clonable oncofetal antigen-specific effector and regulatory T lymphocytes. J Immunol. 1999 Jun 1;162(11):6880-92.

  PMID: 10352310 BACKGROUND

• Coggin JH Jr, Barsoum AL, Rohrer JW. 37 kiloDalton oncofetal antigen protein and immature laminin receptor protein are identical, universal T-cell inducing immunogens on primary rodent and human cancers. Anticancer Res. 1999 Nov-Dec;19(6C):5535-42.

  PMID: 10697612 BACKGROUND

• Zelle-Rieser C, Barsoum AL, Sallusto F, Ramoner R, Rohrer JW, Holtl L, Bartsch G, Coggin JH JR, Thurnher M. Expression and immunogenicity of oncofetal antigen-immature laminin receptor in human renal cell carcinoma. J Urol. 2001 May;165(5):1705-9.

  PMID: 11342960 BACKGROUND

• Coggin JH Jr. Classification of tumor-associated antigens in rodents and humans. Immunol Today. 1994 May;15(5):246-7. doi: 10.1016/0167-5699(94)90251-8. No abstract available.

  PMID: 8024686 BACKGROUND

• Barsoum AL, Coggin JH Jr. Isolation and partial characterization of a soluble oncofetal antigen from murine and human amniotic fluids. Int J Cancer. 1991 May 10;48(2):248-52. doi: 10.1002/ijc.2910480216.

  PMID: 1850386 BACKGROUND

• Payne WJ Jr, Coggin JH Jr. Mouse monoclonal antibody to embryonic antigen: development, cross-reactivity with rodent and human tumors, and preliminary polypeptide characterization. J Natl Cancer Inst. 1985 Sep;75(3):527-44.

  PMID: 2411994 BACKGROUND

• Barsoum AL, Coggin JH Jr. Immunogenicity of a soluble partially purified oncofetal antigen from murine fibrosarcoma in syngeneic mice. J Biol Response Mod. 1989 Dec;8(6):579-92.

  PMID: 2600602 BACKGROUND

• Coggin JH Jr, Barsoum AL, Rohrer JW. Tumors express both unique TSTA and crossprotective 44 kDa oncofetal antigen. Immunol Today. 1998 Sep;19(9):405-8. doi: 10.1016/s0167-5699(98)01305-x. No abstract available.

  PMID: 9745203 BACKGROUND

• Gussack GS, Rohrer SD, Hester RB, Liu PI, Coggin JH Jr. Human squamous cell carcinoma lines express oncofetal 44-kD polypeptide defined by monoclonal antibody to mouse fetus. Cancer. 1988 Jul 15;62(2):283-90. doi: 10.1002/1097-0142(19880715)62:23.0.co;2-o.

  PMID: 3289728 BACKGROUND

• Coggin JH Jr, Rohrer SD, Hester RD, Barsoum AL, Rashid HU, Gussack GS. 44-kd oncofetal transplantation antigen in rodent and human fetal cells. Implications of recrudescence in human and rodent cancers. Arch Otolaryngol Head Neck Surg. 1993 Nov;119(11):1257-66. doi: 10.1001/archotol.1993.01880230105015.

  PMID: 8217085 BACKGROUND

• Coggin JH Jr. Oncofetal antigens. Nature. 1986 Jan 30-Feb 5;319(6052):428. doi: 10.1038/319428c0. No abstract available.

  PMID: 3945319 BACKGROUND

• Coggin JH Jr, Rohrer JW, Barsoum AL. True immunogenicity of oncofetal antigen/immature laminin receptor protein. Cancer Res. 2004 Jul 1;64(13):4685; author reply 4685. doi: 10.1158/0008-5472.CAN-03-2940. No abstract available.

  PMID: 15231682 BACKGROUND

• Rohrer JW, Barsoum AL, Coggin JH Jr. Identification of oncofetal antigen/immature laminin receptor protein epitopes that activate BALB/c mouse OFA/iLRP-specific effector and regulatory T cell clones. J Immunol. 2006 Mar 1;176(5):2844-56. doi: 10.4049/jimmunol.176.5.2844.

  PMID: 16493041 BACKGROUND

• Coggin JH Jr. Embryonic antigens in malignancy and pregnancy: common denominators in immune regulation. Ciba Found Symp. 1983;96:28-54. doi: 10.1002/9780470720776.ch3.

  PMID: 6189676 BACKGROUND

• Rohrer JW, Culpepper C, Barsoum AL, Coggin JH Jr. Characterization of RFM mouse T lymphocyte anti-oncofetal antigen immunity in apparent tumor-free, long-term survivors of sublethal X-irradiation by limiting dilution T lymphocyte cloning. J Immunol. 1995 Mar 1;154(5):2266-80.

  PMID: 7868899 BACKGROUND

• Rohrer JW, Coggin JH Jr. CD8 T cell clones inhibit antitumor T cell function by secreting IL-10. J Immunol. 1995 Dec 15;155(12):5719-27.

  PMID: 7499859 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Kelli Wilson

CONTACT

251 442 9452; kelliwilson@quantumimmunologics.com

Sheri Murray, RN, BSN

CONTACT

251/259-5587; sherimurray@quantumimmunologics.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 10, 2008
• First Posted: July 15, 2008
• Study Start: May 1, 2008
• Primary Completion: February 1, 2010
• Study Completion: February 1, 2015
• Last Updated: August 26, 2009

Record last verified: 2009-08

Locations

US (1)