Vaccine Therapy and Sargramostim With or Without Docetaxel in Treating Patients With Metastatic Lung Cancer or Metastatic Colorectal Cancer

• Status: Terminated
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This randomized phase I trial studies the side effects, best way to give, and best dose of docetaxel when given together with vaccine therapy and sargramostim in treating patients with metastatic lung cancer or metastatic colorectal cancer. Vaccines may make the body build an immune response to kill tumor cells. Colony-stimulating factors such as sargramostim increase the number of immune cells found in bone marrow and peripheral blood. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining vaccine therapy and sargramostim with docetaxel may kill more tumor cells.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

• Histologically confirmed lung OR colorectal cancer

• Incurable metastatic disease

• Currently available standard treatment not likely to offer a survival advantage or result in superior palliation

• Evaluable disease by radiograph

• Tumor must currently express carcinoembryonic antigen (CEA) by immunohistochemistry OR CEA >= 10 ng/mL at any point during disease course

• No clinically active brain metastases

• Must have had first- and second-line treatment OR declined second-line treatment (part I only)

• Patients with colon cancer must have had or have been offered treatment with oxaliplatin (part I only)

• ECOG 0-1

• Life expectancy of at least 4 months

• Absolute neutrophil count >= 1,500/mm^3

• WBC >= 3,000/mm^3

• Platelet count >= 100,000/mm^3

• Bilirubin normal

• Meets 1 of the following criteria:

• SGOT and SGPT =< 2.5 times upper limit of normal (ULN) AND alkaline phosphatase normal

• SGOT and SGPT =< normal AND alkaline phosphatase =<4.0 times ULN

• Hepatitis B and C negative by clinical history and physical exam

• Creatinine =< 1.5 mg/dL OR creatinine clearance >= 60 mL/min

• Proteinuria =< grade 1

• No known or suspected history of impaired cardiac function as evidenced by baseline echocardiogram

• Adequate pulmonary function

• No history or clinical evidence of immune deficiency or autoimmunity

• HIV negative

• No history of or concurrent diagnosis of any of the following:

• Altered immunodeficiency

• Eczema or other eczematoid skin disorders

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

• No history of allergy or untoward reaction to prior vaccination with vaccinia virus

• No history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80

• No history of allergy to eggs or egg products

• No frequent vomiting or severe anorexia

• No inflammatory bowel disease

• No Crohn's disease

• No ulcerative colitis

• No active diverticulitis

• Neuropathy =< grade 1 (sensory neuropathy)

• No uncontrolled seizure disorder

• No encephalitis

• No multiple sclerosis

• Must be maintaining a reasonable state of nutrition (=< 10 % weight loss in the past month)

• Must be able to avoid close household contact (defined as sharing housing or having close physical contact) for at least 3 weeks after recombinant vaccinia vaccination with individuals with active or a history of eczema or other eczematoid skin disorders

• Must be able to avoid close household contact (defined as sharing housing or having close physical contact) for at least 3 weeks after recombinant vaccinia vaccination with those with unresolved acute, chronic, or exfoliative skin conditions (e.g., atopic dermatitis, burns, impetigo, varicella zoster, severe acne, or other open rashes or wounds)

• Must be able to avoid close household contact (defined as sharing housing or having close physical contact) for at least 3 weeks after recombinant vaccinia vaccination with any of the following individuals: pregnant or nursing women; children =< 5 years of age; immunodeficient or immunosuppressed individuals (by disease or therapy), including HIV infection

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception during and for at least 6 months after study participation

• No other concurrent serious medical illness that would preclude study participation

• No concurrent biologic therapy

• No other concurrent immunotherapy

• At least 6 weeks since prior nitrosoureas or mitomycin

• Prior docetaxel allowed (part I only)

• No prior docetaxel (part II only)

• No other concurrent chemotherapy

• No concurrent systemic steroids except for the following:

• physiologic doses for systemic steroid replacement therapy

• local (topical, nasal, or inhaled) steroid use

• no concurrent steroid eye drops

• premedication prior to and after docetaxel

• No concurrent hormonal therapy

• No prior radiotherapy to > 50 % of all nodal groups

• More than 21 days since prior major surgery

• No prior splenectomy

• Recovered from prior therapy

• At least 3-4 weeks since prior cytotoxic therapy