Vaccine Therapy With or Without Docetaxel in Treating Patients With Metastatic Prostate Cancer

• Status: Completed
• Trial end date: 2007-10-01
• Target enrollment: 0
• Participant gender: Male

Summary

RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining vaccine therapy with chemotherapy may kill more tumor cells.

PURPOSE: Randomized phase II trial to compare the effectiveness of vaccine therapy with or without docetaxel in treating patients who have metastatic prostate cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Docetaxel; Sargramostim; Vaccines

Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of androgen-independent metastatic adenocarcinoma of the prostate, confirmed by 1 of the following:

• Histologically confirmed disease

• Pathologically documented disease and clinical course consistent with prostate cancer

• Castrate levels of testosterone with progressive disease by at least 1 of the following parameters:

• 2 consecutively rising prostate-specific antigen levels, separated by at least 1 week, with at least 1 measurement that is 50% above the nadir reached after the last therapeutic maneuver (must be at least 5 ng/mL)

• At least 1 new metastatic deposit on technetium Tc 99 bone scintigraphy

• Progression of soft-tissue metastases by imaging or palpation, as indicated by:

• Development of new area of malignant disease

• At least 20% increase in sum of the longest dimension of target lesions

• Serum testosterone less than 50 ng/dL if no prior surgical castration

• Luteinizing hormone-releasing hormone therapy must continue

• HLA-A2 positive

• No brain metastases

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• ECOG 0-2

Life expectancy

• More than 6 months

Hematopoietic

• Granulocyte count at least 1,500/mm^3

• Lymphocyte count at least 500/mm^3

• Platelet count at least 100,000/mm^3

Hepatic

• Bilirubin less than 1.5 mg/dL

• AST and ALT less than 2.5 times upper limit of normal (ULN)

• Alkaline phosphatase no greater than 2.5 times ULN OR

• Hepatic alkaline phosphatase fraction less than 2.5 times ULN

Renal

• Creatinine no greater than 1.5 mg/dL OR

• Creatinine clearance at least 40 mL/min

• Proteinuria grade 0-1 OR

• Protein less than 1,000 mg by 24-hour urine collection

• No hematuria

• No abnormal sediment unless non-renal

Cardiovascular

• No unstable or newly diagnosed angina pectoris

• No myocardial infarction within the past 6 months

• No New York Heart Association class II-IV congestive heart failure

• No concurrent clinically significant cardiomyopathy requiring treatment

Immunologic

• No prior allergy or untoward reaction to vaccinia virus vaccination

• No altered immune function, including:

• Eczema

• Atopic dermatitis

• HIV

• Autoimmune disease

• Autoimmune neutropenia

• Thrombocytopenia

• Hemolytic anemia

• Systemic lupus erythematosus

• Sjogren's syndrome

• Scleroderma

• Myasthenia gravis

• Goodpasture syndrome

• Addison's disease

• Hashimoto's thyroiditis

• Active Graves' disease

• Multiple sclerosis

• No extensive psoriasis, severe acneiform rash, impetigo, varicella zoster, burns, or other traumatic or pruritic skin condition

• No known allergy to eggs

Other

• No other malignancy within the past 2 years except nonmelanoma skin cancer or carcinoma in situ of the bladder

• No other life-threatening or serious illness

• No unhealed surgical scars

• No household or close physical contact with persons with any of the following conditions during or for 2 weeks after study treatment:

• Eczema or eczematoid skin disorders

• Acute, chronic, or exfoliative skin conditions (e.g., atopic dermatitis, burns, impetigo, varicella zoster, severe acne, or other open rashes or wounds)

• Pregnant or nursing women

• Children under 5 years of age

• Immunodeficient or immunosuppressed (including HIV positive) individuals

• No history of seizures or encephalitis

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• No prior taxanes for metastatic prostate cancer

Endocrine therapy

• See Disease Characteristics

• At least 4 weeks since prior flutamide

• At least 6 weeks since prior bicalutamide or nilutamide

• No concurrent steroids except topical steroids, inhaled steroids for mild or moderate asthma, or decadron as premedication for chemotherapy

Radiotherapy

• Not specified

Surgery

• See Disease Characteristics

• No prior splenectomy

Other

• Recovered from prior therapy