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Completed

NCT Number: NCT00698711

Vaccination of Prostate Cancer Patients With MUC-2-KLH Conjugate Plus the Immunological Adjuvant QS21

The purpose of this research is to help us study a vaccine treatment for patients with prostate cancer. A vaccine is a medicine that teaches the body to destroy harmful infections and other foreign substances. The immune system is made up of many different types of cells, which fight infection and disease in your body. A vaccine may stimulate the immune system to destroy the cancer cells. It may also help to slow the growth of the cancer. The vaccine is a solution given as an injection given into or under the skin. It is made up of several parts. The first part is MUC-2, a protein present in many cancers, especially prostate cancer. MUC-2 is attached to a material called KLH or keyhole limpet hemocyanin. KLH is purified from a snail- like marine mollusk called a keyhole limpet and has been used for many years to boost immune responses in animals and in people. Attaching MUC-2 to KLH helps the immune system react to MUC-2. The mixture of MUC-2 attached to KLH is in turn mixed with a material called QS21, from the bark of a tree, which also helps the immune system to make more cancer- fighting cells. A vaccine like the one you will receive has been given to laboratory animals and been shown to produce an immune response in these animals.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Memorial Sloan-Kettering Cancer Center

New York, 10065, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with prostate cancer that is histologically confirmed by the Department of Pathology at MSKCC will be considered if they show progression of disease based on biochemical parameters. Patients with radiographic evidence of disease are not eligible.
  • Hormonal status will be recorded on the basis of serum testosterone levels.
  • Patients who have progressed after primary therapy to include surgery or radiation (with or without neo-adjuvant androgen ablation), or intermittent hormonal treatment who have non-castrate levels of testosterone (>50 ng/ml). Patients with soft tissue and/or bone disease or patients who are androgen- independent with no evidence of radiographic disease are not eligible. Those patients who are symptomatic or who are anticipated to develop symptoms within 6 months of entry will be excluded.
  • Patients should have no change in their hormone therapies (with the exception of therapies needed to maintain castrate levels of testosterone), including prednisone or dexamethasone within two weeks prior to entry into study.
  • Patients must have evaluable disease (by serial changes in PSA).
  • Karnofsky performance status >60%.
  • Patients must have adequate organ function as defined by:
  • WBC > or = to 3500/mm3 platelet count > or = to 100,000 mm3.
  • Bilirubin < or = 2.0 rag/100 ml or SGOT <3.0 X's the upper limit of normal.
  • Creatinine < or = 2.0 mg/100 ml or creatinine clearance > or = 40 cc/min.
  • Patients must have recovered from the toxicity of any prior therapy, and not received chemotherapy or radiation therapy for at least 4 weeks prior to entry into the trial.
  • No history of an active secondary malignancy within the prior five years except for nonmelanoma skin cancer.
  • Patients must be at least 18 years of age.
  • Patients who have previously received suramin, may be treated if they have been off this drug for at least 8 weeks and/or ha ve a documented plasma concentration below 50 mg/ml. For these patients, replacement doses of hydrocortisone are permitted.
  • Patients must sign informed consent.
  • Registration to IRB Protocol 90-40 (Correlative studies in human prostate cancer).

Exclusion criteria

  • Clinically significant cardiac disease (New York Heart Association Class III/IV), or severe debilitating pulmonary disease.
  • Active CNS or epidural tumor.
  • An infection requiring antibiotic treatment.
  • Narcotic dependent pain.
  • Anticipated survival of less than 6 months.
  • Positive stool guaiac excluding hemorrhoids or history of documented radiation induced proctitis.
  • Allergy to seafood.
  • Patients with radiographic evidence of metastatic disease.

Treatment and study plan

MUC-2-KLH

Biological

The MUC-2-KLH conjugate will be administered subcutaneously to random sites on the upper arm and upper leg at weekly intervals for 3 weeks. This will be followed by a 4 week break and then a fourth vaccination during week 7, and 3 months later during week 19. Booster vaccinations may be given at or after week 50 and 100, and every 6 months thereafter to select patients who show no evidence of radiographic disease progression.

After 5 patients have been enrolled and completed two vaccinations without Grade II or greater toxicity, we will proceed to the next higher dose level. No dose escalations will be performed in the same patient.

Primary outcomes

  1. To determine an optimal dose of the MUC-2-KLH conjugate plus the immunological adjuvant QS21 in patient with prostate cancer that Induces an antibody response to MUC-2. and induces helper T and/or cytotoxic T cell response against MUC -2.

    Time frame: conclusion of study

  2. To determine the safety of immunization with MUC-2-KLH conjugate prepared using an MBS heterobifunctional linker plus QS21.

    Time frame: conclusion of study

  3. To determine the effect of MUC-2-KLH dose on the T cell response against MUC-2 and by skin testing.

    Time frame: conclusion of study

Secondary outcomes

  1. To assess post-immunization changes in prostate specific antigen levels and other objective parameters or disease (radionuclide bone scan and/or measurable disease if present).

    Time frame: conclusion of study

  2. To monitor changes in serum CASA levels prior to and following treatment.

    Time frame: conclusion of study

  3. To monitor sequentially, the peripheral blood for the presence of PSA mRNA in circulating cells using a PCR based assay.

    Time frame: conclusion of study

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Official study title

Vaccination of Prostate Cancer Patients With MUC-2-KLH Conjugate Plus the Immunological Adjuvant QS21: A Trial Comparing MUC-2-KLH Doses

Important dates

Study start
1997
Primary completion
2009
Study completion
2009
First posted
Jun 17, 2008
Registry last updated
Jan 31, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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