Vaccine Therapy in Treating Patients With Metastatic Solid Tumors
Intra-Lesional rF-B7.1 Versus rF-Tricom Vaccine In The Treatment Of Metastatic Cancer
Przegląd badań
Status
Szczegółowy opis
PRIMARY OBJECTIVES:
I. To determine and compare the feasibility and clinical toxicity of administering rF-B7.1 and rF-TRICOM vaccines to patients with accessible cutaneous, subcutaneous, or lymph node metastatic tumors.
II. To determine and compare the feasibility and clinical toxicity of administering rF-B7.1 and rF-TRICOM vaccines to patients with accessible visceral metastatic tumors.
III. To determine the optimal dose of rF-B7.1 and rF-TRICOM vaccine delivered by intra-tumoral injection.
IV. To compare the clinical responses and safety profile of patients with cutaneous tumors and visceral tumors who receive rF-B7.1 vaccine to similar patients receiving rF-TRICOM vaccine.
SECONDARY OBJECTIVES:
I. To establish evidence of host anti-tumor immune reactivity following intra-lesional vaccine administration and compare any differences between rF-B7.1 and rF-TRICOM in patients with cutaneous tumors and visceral tumors.
II. To evaluate the quality of life during vaccine administration.
OUTLINE: This is a randomized study with dose-escalation component. Patients are stratified according to tumor location (cutaneous, subcutaneous, or lymph node metastases vs visceral metastases). Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive rF-B7.1 vaccine intratumorally on day 1.
ARM II: Patients receive fowlpox-TRICOM vaccine intratumorally on day 1.
Treatment in both arms repeats every 4 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease may receive additional courses.
Three patients from the cutaneous disease (CD) stratum are treated at low-dose in each treatment arm. If no more than 1 of 6 patients experience dose-limiting toxicity (DLT), then 6 additional CD patients are randomized to high-dose treatment. If no more than 1 of these 6 patients experience DLT, then 12 patients from the visceral disease (VD) stratum are randomized to low-dose treatment. If no more than 2 of 12 VD patients experience DLT, then the next cohort of 12 VD patients is randomized to high-dose treatment. If 3 of the original 12 VD patients experience DLT, then 6 additional VD patients receive low-dose treatment. If no more than 3 of 18 patients experience DLT, then 12 VD patients receive high-dose treatment.
Quality of life is assessed at baseline, monthly during therapy, and then at the end of therapy.
Patients are followed every 3 months.
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Faza 1
Kontakty i lokalizacje
Lokalizacje studiów
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New York
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New York, New York, Stany Zjednoczone, 10029
- Mount Sinai Medical Center
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
Inclusion Criteria:
Histologically confirmed metastatic unresectable solid tumors
- Cutaneous, subcutaneous, lymph node, or visceral tumors that are accessible to imaging and injections
- No standard therapy available
At least 1 unidimensionally measurable lesion
- At least 20 mm for visceral lesions
- At least 10 mm for cutaneous, subcutaneous, and nodal lesions
No untreated or edematous metastatic brain lesions
- At least 6 weeks since prior surgery and/or radiotherapy for brain metastases and no evidence of disease or edema on CT scan or MRI
- No ascites or pleural effusions
- No leptomeningeal disease
- Performance status - ECOG 0-1
- More than 3 months
- Absolute granulocyte count at least 3,000/mm^3
- Platelet count at least 100,000/mm^3
- No bleeding diathesis
- Bilirubin no greater than 1.5 mg/dL*
- SGOT/SGPT no greater than 2 times upper limit of normal (ULN)*
- Alkaline phosphatase no greater than 2 times ULN*
- No elevated PT or PTT
- No cirrhosis
- No active hepatitis
- No hepatic insufficiency
- Creatinine no greater than 2.0 mg/dL
- No renal insufficiency
- No chronic obstructive pulmonary disorder
- No active autoimmune disorders
- No active immunologically mediated disease (e.g., severe psoriasis, colitis, idiopathic thrombocytopenic purpura, multiple sclerosis, connective tissue disease, or active rheumatoid arthritis)
- No significant allergy or hypersensitivity to eggs
- No active seizure disorder
- No active or chronic infections
- No other significant medical disease that would preclude study participation
- No other malignancy within the past 5 years except stage I cervical cancer or basal cell carcinoma
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- More than 8 weeks since prior immunotherapy and recovered
- More than 4 weeks since prior chemotherapy and recovered
- At least 4 weeks since prior systemic corticosteroids
- No concurrent corticosteroids
- More than 2 weeks since prior radiotherapy and recovered
- No evidence of bone marrow toxicity from prior radiotherapy
- More than 4 weeks since prior surgery and recovered
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Eksperymentalny: Arm I (recombinant fowlpox-B7.1 vaccine)
Patients receive rF-B7.1 vaccine intratumorally on day 1.
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Badania korelacyjne
Badania pomocnicze
Inne nazwy:
Given intratumorally
Inne nazwy:
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Eksperymentalny: Arm II (recombinant fowlpox-TRICOM vaccine)
Patients receive fowlpox-TRICOM vaccine intratumorally on day 1.
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Badania korelacyjne
Badania pomocnicze
Inne nazwy:
Podawany do guza
Inne nazwy:
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Percentages of the DLTEs
Ramy czasowe: 12 weeks
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Will be summarized and compared between arms, doses, and disease groups using Fisher's exact test.
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12 weeks
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Proportion of patients with any response (CR, PR, or SD)
Ramy czasowe: 12 weeks
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First, the proportion with any response (CR, PR or SD) will be compared to those with no response (PD).
Secondly, the proportion of any response (CR, PR or SD) compared to no response (PD) will be compared between the two treatment arms.
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12 weeks
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Immune response
Ramy czasowe: 12 weeks
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Number of T-cells after treatment compared to those measured at baseline, and difference calculated as after-treatment minus baseline.
First comparison includes all subjects who completed treatment.
Mean change in T-Cells (final-baseline) tested against 0 with 2-tailed, 1-sample t-test, with alpha=.05.
Second analysis compares mean change in T-Cells between arms.
Performed as a 2-tailed, 2 independent samples t-test, with alpha=.05.
Third comparison is a sub-set analysis of patients with melanoma.
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12 weeks
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Change in quality of life, assessed using the FACT-G survey of emotional and functional well being
Ramy czasowe: Baseline to 12 weeks
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A mean observed change in the FACT-G score will be tested against 0 (no change) for the group as a whole.
Secondly, the change in score will be compared between the two treatment arms.
The overall mean change will also be compared to historical controls either from the literature for cancer patients or to the values for non-subject cancer patients receiving other therapies.
Comparisons will be by t-test if the sample distribution meets parametric assumptions.
If not non-parametric procedures will be used.
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Baseline to 12 weeks
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Współpracownicy i badacze
Sponsor
Śledczy
- Główny śledczy: Howard Kaufman, Icahn School of Medicine at Mount Sinai
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów
Zakończenie podstawowe (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Oszacować)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Oszacować)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- NCI-2012-02455
- CPMC-IRB-14535
- CDR0000069189 (Identyfikator rejestru: PDQ (Physician Data Query))
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