Feasibility of Autologous Tumor Cell-TLR9 Agonist Vaccination for Metastatic Colorectal Cancer

Status:

WITHDRAWN

Feasibility of Autologous Tumor Cell-TLR9 Agonist Vaccination for Metastatic Colorectal Cancer

Lead Sponsor:

Stanford University

Conditions:

Colorectal Neoplasms

Anal, Colon, and Rectal Cancers

Eligibility:

All Genders

18+ years

Phase:

PHASE1

Brief Summary

Current therapies for metastatic colorectal cancer only prolong life for approximately 2 years. A more innovative therapy that prolongs life significantly or even cures is needed. Bone marrow transpla...

Detailed Description

As the third most common cancer in incidence and second in mortality, colorectal cancer (CRC) significantly impacts the lives of many Americans.1 In 2008, it is estimated that 148,810 cases will be di...

Eligibility Criteria

Inclusion

Histologically confirmed Stage IV, TxNxM1 colon adenocarcinoma with a surgically accessible primary or metastatic site.
Estimated survival of 6 months or greater
Primary may be in place
Age 18-70
Must have an ECOG performance status of 0 or 1
Must have adequate organ and marrow function. Specifically:
Absolute neutrophil count (ANC) \> 1500/uL
Platelet count \>= 100 x 109/L
Total bilirubin \<= 2.0 x the upper limit of normal (ULN)
Alkaline phosphatase, AST, and/or ALT \<2.5 x the ULN for patients
without evidence of liver metastases; \<5 X ULN for patients with
documented liver metastases
Serum creatinine \< 2.0 mg/dL
Hemoglobin \> 9 g/dL
a. Patients may be transfused or receive epoetin alfa to maintain or exceed this level up to the hemoglobin level recommended on the current label for epoetin alfa. There is concern that hemoglobin levels greater than the level recommended by the current labeling have been associated with the potential increased risk of thrombotic events and increased mortality. Also, a rapid increase in hemoglobin may exacerbate hypertension (a concern in patients with pre-existing hypertension and if bevacizumab is administered).
Cardiac ejection fraction \>40 % by transthoracic echo or MUGA scan within 12 wks of transplant
Adequate pulmonary function tests (PFTs) within 6 wks of transplant
a. DLCO \>=60% predicted
Patients must be HIV negative
No prior therapy which would preclude the use of total body irradiation
Pathology must be reviewed and diagnosis confirmed by Stanford University Medical Center
Ability to understand and the willingness to sign a written informed consent document.
Ability and capacity to comply with the study and follow-up procedures.;

Exclusion

Disease-Specific Exclusions
Radiotherapy within 28 days prior to the day of tumor resection (Day 1).
No myelosuppressive chemotherapy within 28 days prior to the day of tumor resection
History of brain metastases, regardless if treated.
Co-morbid diseases or intercurrent illness
Active infection or fever \> 38.5°C within 3 days of starting treatment
History of other malignancies within 5 years prior to Day 1 except for tumors with a negligible risk for metastasis or death, such as adequately controlled basal cell carcinoma, squamous-cell carcinoma of the skin, carcinoma in situ of the cervix, early-stage bladder cancer, or low-grade endometrial cancer
Malignancies that have undergone a putative surgical cure (i.e., localized prostate cancer post-prostatectomy) within 5 years prior to Day 1 may be discussed with the Medical Monitor.
History or presence of autoimmune disorders requiring treatment
Any other medical conditions (including mental illness or substance abuse) deemed by the clinician to be likely to interfere with a patient's ability to provide informed consent, cooperate, or participate in the study, or to interfere with the interpretation of the results.
Inadequately controlled hypertension (defined as systolic blood pressure \>150 and/or diastolic blood pressure \> 100 mmHg on antihypertensive medications)
Any prior history of hypertensive crisis or hypertensive encephalopathy
New York Heart Association (NYHA) Grade II or greater congestive heart failure (see Appendix A)
History of myocardial infarction or unstable angina within 6 months prior to study enrollment
History of stroke or transient ischemic attack within 6 months prior to study enrollment
Significant vascular disease (e.g., aortic aneurysm, aortic dissection)
Symptomatic peripheral vascular disease
Evidence of bleeding diathesis or coagulopathy that is not intentionally pharmacologically-induced Serious, non-healing wound, ulcer, or bone fracture
Proteinuria at screening as demonstrated by either:
Urine protein: creatinine (UPC) ratio \>= 1.0 at screening OR
Urine dipstick for proteinuria \>= 2+ (patients discovered to have \>=2+ proteinuria on dipstick urinalysis at baseline should undergo a 24 hour urine collection and must demonstrate \<= 1g of protein in 24 hours to be eligible).
Radiation-specific exclusions
o Prior radiation to \>25% of the marrow
Pregnancy
Women who are pregnant or breast feeding, or women/men able to conceive and unwilling to practice an effective method of birth control.
a. Women of childbearing potential must have a negative urine or serum pregnancy test within 7 days of study entry.
Nursing patients will be excluded

Key Trial Info

Start Date :

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

Estimated Enrollment :

Patients enrolled

Trial Details

Trial ID

NCT00780988

Last Update

January 24 2012

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