Adults 18 to 70, any sex, with Metastatic Cancer or Metastatic Melanoma. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Participants With a Response to TherapyPrimary· 5 years
Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response (CR) is disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. Progressive disease (PD) is at least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment starts or the appearance of one or more new lesions. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to
Complete Response (CR)
Group
Value
95% CI
Cohort 1 - 1x10(6) Cells (High Dose IL-2)
0
Cohort 2 - 3x10(6) Cells (High Dose IL-2)
0
Cohort 3 - 1x10(7) Cells (High Dose IL-2)
0
Cohort 4 - 3x10(7) Cells (High Dose IL-2)
0
Cohort 5 - 1x10(8) Cells (High Dose IL-2)
0
Cohort 6 - 3x10(8) Cells (High Dose IL-2)
0
Cohort 7 - 1x10(9) Cells (High Dose IL-2)
0
Cohort 8 - 1x10(9) Cells (Low Dose IL-2)
0
Cohort 9 - 3x10(9) Cells (Low Dose IL-2)
0
Cohort 10 - 1x10(10) Cells (Low Dose IL-2)
0
Cohort 11 - 3x10(10) Cells (Low Dose IL-2)
0
Partial Response (PR)
Group
Value
95% CI
Cohort 1 - 1x10(6) Cells (High Dose IL-2)
0
Cohort 2 - 3x10(6) Cells (High Dose IL-2)
0
Cohort 3 - 1x10(7) Cells (High Dose IL-2)
0
Cohort 4 - 3x10(7) Cells (High Dose IL-2)
0
Cohort 5 - 1x10(8) Cells (High Dose IL-2)
0
Cohort 6 - 3x10(8) Cells (High Dose IL-2)
0
Cohort 7 - 1x10(9) Cells (High Dose IL-2)
0
Cohort 8 - 1x10(9) Cells (Low Dose IL-2)
0
Cohort 9 - 3x10(9) Cells (Low Dose IL-2)
0
Cohort 10 - 1x10(10) Cells (Low Dose IL-2)
1
Cohort 11 - 3x10(10) Cells (Low Dose IL-2)
0
Progressive Disease (PD)
Group
Value
95% CI
Cohort 1 - 1x10(6) Cells (High Dose IL-2)
1
Cohort 2 - 3x10(6) Cells (High Dose IL-2)
1
Cohort 3 - 1x10(7) Cells (High Dose IL-2)
3
Cohort 4 - 3x10(7) Cells (High Dose IL-2)
1
Cohort 5 - 1x10(8) Cells (High Dose IL-2)
1
Cohort 6 - 3x10(8) Cells (High Dose IL-2)
1
Cohort 7 - 1x10(9) Cells (High Dose IL-2)
3
Cohort 8 - 1x10(9) Cells (Low Dose IL-2)
3
Cohort 9 - 3x10(9) Cells (Low Dose IL-2)
3
Cohort 10 - 1x10(10) Cells (Low Dose IL-2)
3
Cohort 11 - 3x10(10) Cells (Low Dose IL-2)
2
Stable Disease (SD)
Group
Value
95% CI
Cohort 1 - 1x10(6) Cells (High Dose IL-2)
0
Cohort 2 - 3x10(6) Cells (High Dose IL-2)
0
Cohort 3 - 1x10(7) Cells (High Dose IL-2)
0
Cohort 4 - 3x10(7) Cells (High Dose IL-2)
0
Cohort 5 - 1x10(8) Cells (High Dose IL-2)
0
Cohort 6 - 3x10(8) Cells (High Dose IL-2)
0
Cohort 7 - 1x10(9) Cells (High Dose IL-2)
1
Cohort 8 - 1x10(9) Cells (Low Dose IL-2)
0
Cohort 9 - 3x10(9) Cells (Low Dose IL-2)
0
Cohort 10 - 1x10(10) Cells (Low Dose IL-2)
0
Cohort 11 - 3x10(10) Cells (Low Dose IL-2)
0
Number of Participants With Serious and Non-Serious Adverse EventsSecondary· Date treatment consent signed to date off study, approximately, 33 months and 25 days
Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v3.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one
Group
Value
95% CI
Cohort 1 - 1 x 10(6) Cells (High Dose IL-2)
1
Cohort 2 - 3 x 10(6) Cells (High Dose IL-2)
1
Cohort 3 - 1 x 10(7) Cells (High Dose IL-2)
3
Cohort 4 - 3 x 10(7) Cells (High Dose IL-2)
1
Cohort 5 - 1 x 10(8) Cells (High Dose IL-2)
1
Cohort 6 - 3 x 10(8) Cells (High Dose IL-2)
1
Cohort 7 - 1 x 10(9) Cells (High Dose IL-2)
4
Cohort 8 - 1 x 10(9) Cells (Low Dose IL-2)
3
Cohort 9 - 3 x 10(9) Cells (Low Dose IL-2)
3
Cohort 10 - 1 x 10(10) Cells (Low Dose IL-2)
3
Cohort 11 - 3 x 10(10) Cells (Low Dose IL-2)
2
Adverse events — posted to ClinicalTrials.gov
Time frame: Date treatment consent signed to date off study, approximately, 33 months and 25 days.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Background:
The National Cancer Institute (NCI) Surgery Branch has developed an experimental therapy for treating patients metastatic cancer that involves taking white blood cells from the patient, growing them in the laboratory in large numbers, genetically modifying these specific cells with a type of virus (retrovirus) to attack only the tumor cells, and then giving the cells back to the patient. This type of therapy is called gene transfer. In this protocol, we are modifying the patient s white blood cells with a retrovirus that has the gene for anti-vascular endothelial growth factor receptor (VEGFR2) incorporated in the retrovirus.
Objectives:
\- To determine a safe number of these cells to infuse and to see the safety and effectiveness of cell therapy using anti-VEGFR2 gene modified tumor white blood cells to treat recurrent or relapsed cancer.
Eligibility:
\- Individuals greater than or equal to 18 years of age and less than or equal to 70 years of age who have been diagnosed with metastatic cancer that has not responded to or has relapsed after standard treatment.
Design:
* Work up stage: Patients will be seen as an outpatient at the National Institutes of Health (NIH) clinical Center and undergo a history and physical examination, scans, x-rays, lab tests, and other tests as needed
* Leukapheresis: If the patients meet all of the requirements for the study they will undergo leukapheresis to obtain white blood cells to make the anti-VEGFR2 cells. {Leukapheresis is a common procedure which removes only the white blood cells from the patient.}
* Treatment: Once their cells have grown the patients will be admitted to the hospital for the conditioning chemotherapy, the anti-VEGFR2 cells and aldesleukin. They will stay in the hospital for about4 weeks for the treatment.
* Follow up: Patients will return to the clinic for a physical exam, review of side effects, lab tests, and scans about every 1-3 months for the first year, and then every 6 months to 1 year as long as their tumors are shrinking. Follow up visits will take up to 2 days.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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NCT07011862 — COBRA: Cancer, Older Adults, Balance and Resistance Activities
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· recruiting
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by National Cancer Institute (NCI)
Last refreshed: 10 December 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01218867.