- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00049699
VNP40101M in Treating Patients With Advanced or Metastatic Cancer
A Phase I Trial of VNP40101M, a Novel Alkylating Agent, Administered Weekly for Patients With Advanced or Metastatic Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.
PURPOSE: Phase I trial to study the effectiveness of VNP40101M in treating patients who have advanced or metastatic cancer.
Studieoversigt
Status
Intervention / Behandling
Detaljeret beskrivelse
OBJECTIVES:
- Determine the toxic effects of VNP40101M in patients with advanced or metastatic solid tumor or lymphoma.
- Determine the maximum tolerated dose of this drug in these patients.
- Determine the pharmacokinetics of this drug in these patients.
- Determine the antitumor effects of this drug in these patients.
OUTLINE: This is a dose-escalation study.
Patients receive VNP40101M IV over 15 minutes on days 1, 8, and 15. Treatment repeats every 28 days.
Cohorts of 3-6 patients receive escalating doses of VNP40101M until the maximum tolerated dose is determined.
PROJECTED ACCRUAL: Approximately 20 patients will be accrued for this study.
Undersøgelsestype
Fase
- Fase 1
Kontakter og lokationer
Studiesteder
-
-
Connecticut
-
New Haven, Connecticut, Forenede Stater, 06520-8028
- Yale Comprehensive Cancer Center
-
West Haven, Connecticut, Forenede Stater, 06516
- Veterans Affairs Medical Center - West Haven
-
-
Ohio
-
Cleveland, Ohio, Forenede Stater, 44106-5065
- Ireland Cancer Center
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
DISEASE CHARACTERISTICS:
- Histologically confirmed advanced or metastatic solid tumor or lymphoma for which no curative or standard effective therapy exists
- Measurable or evaluable disease
- Primary brain tumors or brain metastases allowed provided neurologic deficits are stable and do not preclude study compliance
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- ECOG 0-1
Life expectancy
- At least 3 months
Hematopoietic
- Granulocyte count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
- Hematocrit at least 30% (transfusion allowed)
- No bleeding diathesis
Hepatic
- PT and PTT no greater than 1.5 times the upper limit of normal (ULN)
- Bilirubin no greater than 1.5 times ULN
- ALT and AST no greater than 1.5 times ULN (3 times ULN if liver metastases present)
- Albumin at least 2.5 gm/dL
Renal
- Creatinine no greater than 2.0 mg/dL
Cardiovascular
- At least 3 months since prior myocardial infarction
- No symptomatic coronary artery disease
- No arrhythmias requiring medication
- No uncontrolled congestive heart failure
Pulmonary
- No dyspnea on minimal or moderate exertion
- DLCO and FEV1 at least 60% predicted
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No uncontrolled active bleeding (e.g., active peptic ulcer disease)
- No active infection
- HIV negative
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Recovered from acute toxicities of prior biologic therapy (persisting, chronic toxicity allowed if stable and no greater than grade 1)
Chemotherapy
- More than 6 months since prior high-dose chemotherapy with stem cell support
- More than 3 weeks since prior cytotoxic chemotherapy (6 weeks for mitomycin or nitrosoureas)
- Recovered from acute toxicities of prior chemotherapy (persisting, chronic toxicity allowed if stable and no greater than grade 1)
Endocrine therapy
- At least 2 weeks since prior hormonal therapy
Radiotherapy
- Recovered from acute toxicities of prior radiotherapy (persisting, chronic toxicity allowed if stable and no greater than grade 1)
Surgery
- At least 2 weeks since prior surgery
Other
- No other concurrent standard or investigational treatment for cancer
- No concurrent disulfiram
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
- uspecificeret voksen solid tumor, protokol specifik
- stadium IV grad 3 follikulært lymfom
- stadium IV voksent diffust storcellet lymfom
- stadium IV voksen immunoblastisk storcellet lymfom
- stadium IV voksen Burkitt lymfom
- tilbagevendende grad 3 follikulært lymfom
- tilbagevendende voksent diffust storcellet lymfom
- tilbagevendende voksen immunoblastisk storcellet lymfom
- recidiverende voksen Burkitt lymfom
- recidiverende voksen Hodgkin lymfom
- recidiverende voksent diffust små spaltet celle lymfom
- recidiverende voksent diffust blandet celle lymfom
- stadium IV grad 1 follikulært lymfom
- stadium IV grad 2 follikulært lymfom
- stadium IV voksent diffust små spaltet celle lymfom
- stadium IV voksent diffust blandet celle lymfom
- stadium IV mantelcellelymfom
- tilbagevendende grad 1 follikulært lymfom
- tilbagevendende grad 2 follikulært lymfom
- tilbagevendende marginal zone lymfom
- tilbagevendende lille lymfocytisk lymfom
- stadium IV lille lymfocytisk lymfom
- stadium IV marginal zone lymfom
- ekstranodal marginal zone B-celle lymfom af slimhinde-associeret lymfoid væv
- nodal marginal zone B-celle lymfom
- milt marginal zone lymfom
- tilbagevendende lymfoblastisk lymfom hos voksne
- tilbagevendende kappecellelymfom
- primært non-Hodgkin lymfom i centralnervesystemet
- stadium IV voksen Hodgkin lymfom
- stadium IV kutant T-celle non-Hodgkin lymfom
- tilbagevendende kutant T-celle non-Hodgkin lymfom
- tyndtarms lymfom
- stadium IV voksen lymfoblastisk lymfom
- stadium IV voksen T-celle leukæmi/lymfom
- tilbagevendende voksen T-celle leukæmi/lymfom
- intraokulært lymfom
- angioimmunoblastisk T-celle lymfom
- anaplastisk storcellet lymfom
- stadium IV mycosis fungoides/Sezary syndrom
- tilbagevendende mycosis fungoides/Sezary syndrom
Yderligere relevante MeSH-vilkår
- Sygdomme i fordøjelsessystemet
- Patologiske processer
- Sygdomme i immunsystemet
- Neoplasmer efter histologisk type
- Neoplasmer
- Lymfoproliferative lidelser
- Lymfesygdomme
- Immunproliferative lidelser
- Neoplasmer efter sted
- Gastrointestinale neoplasmer
- Neoplasmer i fordøjelsessystemet
- Gastrointestinale sygdomme
- Tarmsygdomme
- Neoplastiske processer
- Lymfom
- Neoplasma Metastase
- Intestinale neoplasmer
Andre undersøgelses-id-numre
- VION-CLI-028
- CDR0000258355 (Registry Identifier: PDQ (Physician Data Query))
- YALE-HIC-16775
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .