Melanoma (Skin)NCT01005537
Cyclophosphamide, Autologous Lymphocytes, and Aldesleukin in Treating Patients With Metastatic Melanoma
A study testing aldesleukin, therapeutic autologous lymphocytes and cyclophosphamide in people with Melanoma (Skin), run by Fred Hutchinson Cancer Center.
Trial summary
RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Melanoma (Skin)
- What is being tested?
- aldesleukin, therapeutic autologous lymphocytes and cyclophosphamide
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Jun 2009to Oct 2010
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histopathological documentation of melanoma concurrent with the diagnosis of metastatic disease.
- 18 to 75 years of age and able to tolerate high-dose cyclophosphamide
- Bi-dimensionally measurable disease by palpation on clinical exam, or radiographic imaging (X-ray, CT scan).
- For patients receiving HD-IL-2, normal cardiac stress test within 182 days prior to enrollment is required of all patients over 50 years old or those with an abnormal ECG, any history of cardiac disease, a family history of cardiac disease, hypercholesterolemia or hypertension.
- For leukapheresis, patients must meet the following criteria (any exceptions to this will require prior approval by the Apheresis director and Principal Investigator):
- Pulse: >45 or < 120
Show all 12Show fewer
- Weight: >45 kg
- Temperature: <38C (<100.4 F)
- WBC: >3,000
- HCT: >30%
- Platelets: >100,000
- ADDITIONAL INCLUSION CRITERIA FOR T CELL INFUSION
Who cannot join
- Significant cardiovascular abnormalities as defined by any one of the following:
- congestive heart failure,
- clinically significant hypotension,
- symptoms of coronary artery disease,
- presence of cardiac arrhythmias on EKG requiring drug therapy
- ejection fraction < 50 % (echocardiogram or MUGA)
- Patients with active infections or oral temperature > 38.2 C within 72 hours of study entry or systemic infection requiring chronic maintenance or suppressive therapy.
About this study
Official title: Single Patient Study to Evaluate Cellular Adoptive Immunotherapy Using Autologous Lymphocytes Following Cyclophosphamide Conditioning for a Single Patient With Metastatic Melanoma
RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Biological therapy, such as cellular adoptive immunotherapy using autologous lymphocytes, may stimulate the immune system in different ways and stop tumor cells from growing. Aldesleukin may stimulate the lymphocytes to kill tumor cells. Giving cyclophosphamide together with autologous lymphocytes and aldesleukin may be an effective treatment for metastatic melanoma.
PURPOSE: This phase I/II trial is studying the side effects of giving cyclophosphamide together with autologous lymphocytes and aldesleukin and to see how well it works in treating patients with metastatic melanoma.
Read the detailed description
OBJECTIVES:
Primary
- Assess the safety and toxicity of cellular adoptive immunotherapy with autologous tumor-infiltrating lymphocytes (TIL) following cyclophosphamide conditioning and post-infusion aldesleukin (IL-2) in patients with metastatic melanoma.
- Assess the duration of in vivo persistence of adoptively transferred lymphocytes.
Secondary
- Evaluate the antitumor effect of adoptively transferred autologous TIL following cyclophosphamide conditioning and post-infusion IL-2 in these patients.
OUTLINE: Patients receive cyclophosphamide IV on days -3 and -2 and autologous tumor-infiltrating lymphocytes (TIL) IV on day 0. Beginning 6 hours after TIL infusion, patients receive high-dose aldesleukin (IL-2) IV three times daily on days 0-5 (for up to 14 doses) OR low-dose IL-2 subcutaneously twice daily on days 0-14 (for up to 28 doses). Patients may then receive two additional courses of TILs and low-dose IL-2 (with or without cyclophosphamide), if indicated.
After completion of study treatment, patients are followed up periodically.
- Conditions
- Melanoma (Skin)
- Being tested
- aldesleukin, therapeutic autologous lymphocytes, cyclophosphamide
- Keywords
- stage IV melanoma
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aldesleukinBiological
Given IV and orally
therapeutic autologous lymphocytesBiological
Given IV
cyclophosphamideDrug
Given IV
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2009 (estimated)
- Study startJun 2009
- Primary completionOct 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Melanoma (Skin)Studies of the same condition, open and under way.
- More trials run by Fred Hutchinson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Fred Hutchinson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Cassian Yee, MD, Principal investigator, Fred Hutchinson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01005537
- Sponsor's protocol ID
- 2355.00
- Other IDs
- P30CA015704, FHCRC-2355.00, IR-6984, CDR0000648071
- Status last verified
- Aug 2010
- First submitted
- 30 Oct 2009
- Last updated
- 6 Aug 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Patient Study to Evaluate Cellular Adoptive Immunotherapy Using Autologous Lymphocytes Following Cyclophosphamide Conditioning for a Single Patient With Metastatic Melanoma
- ClinicalTrials.gov ID
- NCT01005537
- Acronym / sponsor ID
- 2355.00
- Conditions
- Melanoma (Skin)
- Keywords
- stage IV melanoma
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- Fred Hutchinson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jun 2009
- Primary completion
- Oct 2010 (estimated)
- First posted
- 2 Nov 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Biological therapy, such as cellular adoptive immunotherapy using autologous lymphocytes, may stimulate the immune system in different ways and stop tumor cells from growing. Aldesleukin may stimulate the lymphocytes to kill tumor cells. Giving cyclophosphamide together with autologous lymphocytes and aldesleukin may be an effective treatment for metastatic melanoma.
PURPOSE: This phase I/II trial is studying the side effects of giving cyclophosphamide together with autologous lymphocytes and aldesleukin and to see how well it works in treating patients with metastatic melanoma.
Detailed description
OBJECTIVES:
Primary
- Assess the safety and toxicity of cellular adoptive immunotherapy with autologous tumor-infiltrating lymphocytes (TIL) following cyclophosphamide conditioning and post-infusion aldesleukin (IL-2) in patients with metastatic melanoma.
- Assess the duration of in vivo persistence of adoptively transferred lymphocytes.
Secondary
- Evaluate the antitumor effect of adoptively transferred autologous TIL following cyclophosphamide conditioning and post-infusion IL-2 in these patients.
OUTLINE: Patients receive cyclophosphamide IV on days -3 and -2 and autologous tumor-infiltrating lymphocytes (TIL) IV on day 0. Beginning 6 hours after TIL infusion, patients receive high-dose aldesleukin (IL-2) IV three times daily on days 0-5 (for up to 14 doses) OR low-dose IL-2 subcutaneously twice daily on days 0-14 (for up to 28 doses). Patients may then receive two additional courses of TILs and low-dose IL-2 (with or without cyclophosphamide), if indicated.
After completion of study treatment, patients are followed up periodically.
Study design
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Histopathological documentation of melanoma concurrent with the diagnosis of metastatic disease.
- 18 to 75 years of age and able to tolerate high-dose cyclophosphamide
- Bi-dimensionally measurable disease by palpation on clinical exam, or radiographic imaging (X-ray, CT scan).
- For patients receiving HD-IL-2, normal cardiac stress test within 182 days prior to enrollment is required of all patients over 50 years old or those with an abnormal ECG, any history of cardiac disease, a family history of cardiac disease, hypercholesterolemia or hypertension.
- For leukapheresis, patients must meet the following criteria (any exceptions to this will require prior approval by the Apheresis director and Principal Investigator):
Key exclusion criteria (7 listed)
- Significant cardiovascular abnormalities as defined by any one of the following:
- Patients with active infections or oral temperature > 38.2 C within 72 hours of study entry or systemic infection requiring chronic maintenance or suppressive therapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| aldesleukinGiven IV and orally | Biological | – |
| therapeutic autologous lymphocytesGiven IV | Biological | – |
| cyclophosphamideGiven IV | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cassian Yee, MD principal investigator
Fred Hutchinson Cancer Center
Questions about this trial
What is this clinical trial studying?
A study testing aldesleukin, therapeutic autologous lymphocytes and cyclophosphamide in people with Melanoma (Skin), run by Fred Hutchinson Cancer Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2010.