Neoplasms

Symptoms and General Pathology

All Conditions

Skin and Connective Tissue Diseases

Rare Diseases

Neoplasm Metastasis

Melanoma

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Neoplastic Processes

Neuroendocrine Tumor

Neuroepithelioma

Anti-Infective Agents

Antineoplastic Agents

All Drugs and Chemicals

Analgesics

Aldesleukin

Interleukin-2

Analgesics, Non-Narcotic

Anti-HIV Agents

Anti-Retroviral Agents

Antiviral Agents

Interleukin-2 (Proleukin)

Claus Garbe, MD

The intra-/perilesional application of interleukin-2 seems to be a safe and effective treatment of skin and soft tissue metastases in malignant melanoma. Especially in case of intransit metastases the overall survival rate is still 20-30%.

However, the management of intransit metastases is sometimes difficult because of frequent recurrences. IL-2 intralesionally seems to be an non-invasive option as pilot studies indicate. In this study the safety and efficacy of IL-2 are evaluated.

Intralesional Treatment With Interleukin-2 (Proleukin) in Soft Tissue Melanoma Metastases

Intralesional Treatment With Interleukin-2 (Proleukin) in Soft Tissue Melanoma Metastases. A Phase II, Prospective, Open, Multicenter Trial

University Hospital Tuebingen

Skin Cancer Programme

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Prostatic Neoplasms

Adenocarcinoma

Recurrence

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Hormones

Immunomodulating Agents

Patients receive sipuleucel-T IV over 60 minutes days 22, 36, and 50.

Patients undergo external beam radiation therapy in weeks 1-2. Patients also receive sipuleucel-T as in Arm A.

sipuleucel-T

external beam radiation therapy

laboratory biomarker analysis

Cy Stein, MD, PhD

This randomized phase II trial studies how well giving sipuleucel-T with or without radiation therapy works in treating patients with hormone-resistant metastatic prostate cancer. Vaccines may help the body build an effective immune response to kill tumor cells. Radiation therapy uses high energy x rays to kill tumor cells. It is not yet known whether giving sipuleucel-T vaccine is more effective with or without radiation therapy in treating prostate cancer

PRIMARY OBJECTIVES:

I. To assess the feasibility, based on percent able or willing to receive all three infusions of sipuleucel-T immunotherapy, when combining sipuleucel-T with radiation therapy to a single site of metastasis delivered one week prior to beginning of sipuleucel-T therapy.

SECONDARY OBJECTIVES:

I. To assess the effect of radiation therapy to single metastasis on immune response (antibody and T-cell proliferation to prostate acid phosphate \[PAP\] and fusion protein PA2024) generated by sipuleucel-T immunotherapy.

II. To assess the effect of external beam radiotherapy to single metastasis on prostate specific antigen (PSA) response to therapy with sipuleucel-T.

III. To assess the effect of external beam radiotherapy to single metastasis on radiographic response rate to therapy with sipuleucel-T.

IV. To assess the time from the onset of therapy with sipuleucel-T +/- radiation to the need for subsequent therapy for prostate cancer.

V. To assess the toxicity associated with sipuleucel-T +/- radiation.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM A: Patients receive sipuleucel-T intravenously (IV) over 60 minutes days 22, 36, and 50.

ARM B: Patients undergo external beam radiation therapy in weeks 1-2. Patients also receive sipuleucel-T as in Arm A.

In both arms, treatment continues in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up until week 60.

Sipuleucel-T With or Without Radiation Therapy in Treating Patients With Hormone-Resistant Metastatic Prostate Cancer

Randomized Phase II Trial of Sipuleucel T Immunotherapy Preceded by Sensitizing Radiation Therapy and Sipuleucel-T Alone in Patients With Castrate Resistant Metastatic Prostate Cancer

Estimated using the product-limit method of Kaplan and Meier.

Progression is defined as one or more of the following:

20% increase in the sum of the longest diameters of target measurable lesions over the smallest sum observed (over baseline if no decrease during therapy) using the same techniques as baseline; unequivocal progression of non-measurable disease in the opinion of the treating physician; appearance of any new lesions; PSA increase of 25% from baseline or nadir and by 2ng/uL or greater at 12 weeks; death due to disease without prior documentation of progression and without symptomatic deterioration.

Number of participants with specified adverse event that is grade 2 or above and related to treatment. Graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0

National Cancer Institute (NCI)

City of Hope Medical Center

"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.

Patients receive sipuleucel-T IV over 60 minutes days 22, 36, and 50. Each dose of sipuleucel-T contains a minimum of 50 million activated CD54+ cells.

sipuleucel-T: Given IV

laboratory biomarker analysis: Correlative studies

Arm A (Sipuleucel-T)

Patients undergo external beam radiation therapy in weeks 1-2. Radiation given in 10 fractions of 300cGy for a total dose of 3000cGy. Patients also receive sipuleucel-T as in Arm A.

sipuleucel-T: Given IV

external beam radiation therapy: Undergo external beam radiation therapy

laboratory biomarker analysis: Correlative studies

Arm B (Radiation Therapy, Sipuleucel-T)

Total

Age, Continuous

Sex: Female, Male

Caucasian

Hispanic

Asian

African American

Not Reported

Race/Ethnicity, Customized

United States

Region of Enrollment

Gleason Scores range from 2-10. Summing scores (1-5) of common (primary) and second most common (secondary) patterns of cells found in a tissue sample. The higher the Gleason Score, the more likely that the cancer will grow and spread quickly. Scores of 6 or less describe cancer cells that look similar to normal cells and suggest that the cancer is likely to grow slowly. A score of 7 suggests intermediate risk for aggressive cancer. Scores of 8 or higher describe cancers that are likely to spread more rapidly, these cancers are referred to as poorly differentiated or high grade.

Gleason Score

Paul Frankel, Ph.D.

Progression-free Survival

Grade 2 : Chills

Grade 2 : Fatigue

Grade 2 : Infusion Reaction

Grade 2 : Decreased Lymphocyte Count

Grade 2 : Nausea

Grade 2 : Pain in Extremity

Grade 2 : Anemia

Grade 2 : Anorexia

Grade 2 : Headache

Grade 2 : Hypertension

Grade 3 : Chills

Grade 3 : Fatigue

Grade 3 : Infusion Reaction

Grade 3 : Decreased Lymphocyte Count

Grade 3 : Nausea

Grade 3 : Pain in Extremity

Grade 3 : Anemia

Grade 3 : Anorexia

Grade 3 : Headache

Grade 3 : Hypertension

Number of Participants With Grade 2 or Above Adverse Events

Overall Study

Breast Neoplasms

Neoplasms, Second Primary

Breast Diseases

Anti-Arrhythmia Agents

Vasodilator Agents

Micronutrients

Mineral

Antibodies

Trastuzumab

Fluorodeoxyglucose F18

Immunoglobulins

Ado-Trastuzumab Emtansine

Adenosine

Copper

Maytansine

Immunoconjugates

Antineoplastic Agents, Immunological

Radiopharmaceuticals

Trace Elements

Tubulin Modulators

Antimitotic Agents

Immunotoxins

Immunologic Factors

Copper Supplement

Patients undergo whole body fludeoxyglucose F 18 PET/CT. Patients then receive trastuzumab IV over 15 minutes immediately before receiving copper Cu 64-DOTA-trastuzumab IV and then undergo PET scans at 24 and 48 hours. Patients then receive ado-trastuzumab emtansine IV every 3 weeks until complete response or disease progression at the discretion of the treating oncologist. Patients undergo restaging by whole body fludeoxyglucose F 18 PET/CT every 6 weeks after initiation of treatment until disease progression.

fludeoxyglucose F 18

positron emission tomography

computed tomography

trastuzumab

copper Cu 64-DOTA-trastuzumab

ado-trastuzumab emtansine

Joanne Mortimer

This pilot clinical trial studies how well copper Cu 64-tetra-azacyclododecanetetra-acetic acid (DOTA)-trastuzumab positron emission tomography (PET) works in predicting response to treatment with ado-trastuzumab emtansine in patients with human epidermal growth factor receptor 2 (HER2) positive breast cancer that has spread to other places in the body. Copper Cu 64-DOTA-trastuzumab is a chemotherapy drug (trastuzumab) attached to a radioactive substance. Diagnostic procedures using PET may allow scanners to take pictures of where the drug travels in the body and may help doctors identify which patients may benefit from treatment with ado-trastuzumab emtansine.

PRIMARY OBJECTIVES:

I. Correlate uptake of 64Cu-DOTA-trastuzumab (copper Cu 64-DOTA-trastuzumab) PET by individual tumors with subsequent tumor response to ado-trastuzumab emtansine as assessed by serial 18F-fludeoxyglucose (FDG) (fludeoxyglucose F 18)/PET-computed tomography (CT).

II. Compare tumor uptake of 64Cu-DOTA-trastuzumab PET between patients who do and patients who do not respond to ado-trastuzumab emtansine.

III. Obtain tumor tissue for subsequent assessment of the presence of putative molecular mechanisms of resistance (MMRs) to ado-trastuzumab emtansine. When funding becomes available, those samples will be used to explore the correlation between the presence of MMRs as assessed by histopathology and tumor response to ado-trastuzumab emtansine both in univariate analysis and in combination with tumor uptake of 64Cu-DOTA-trastuzumab as measured with PET/CT.

OUTLINE:

Patients undergo whole body fludeoxyglucose F 18 PET/CT. Patients then receive trastuzumab intravenously (IV) over 15 minutes immediately before receiving copper Cu 64-DOTA-trastuzumab IV and then undergo PET scans at 24 and 48 hours. Patients then receive ado-trastuzumab emtansine IV every 3 weeks until complete response or disease progression at the discretion of the treating oncologist. Patients undergo restaging by whole body fludeoxyglucose F 18 PET/CT every 6 weeks for 1 year after initiation of treatment until disease progression.

After completion of study treatment, patients are followed up for 1 year.

Copper Cu 64-DOTA-Trastuzumab PET in Predicting Response to Treatment With Ado-Trastuzumab Emtansine in Patients With Metastatic HER2 Positive Breast Cancer

A Pilot Study of 64Cu-DOTA-Trastuzumab Positron Emission Tomography in Treatment of Advanced HER2 Positive Breast Cancer With the Antibody Drug Conjugate Ado-trastuzumab Emtansine

Relationship between patient best response to T-DM1 and measured tumor uptake of 64Cu-DOTA-trastuzumab employed a t-test with a 0.05 two-sided significance level comparing average uptake in responsive vs non-responsive patients. Tumor uptake measured as SUV defined as SUV = AC(tsc) Wb /\[Dinj exp(-λ(tsc - tinj)\] , where AC(tsc) is the activity concentration in the volume of interest (VOI, e. g., a tumor), Wb is the patient's body weight, Dinj is the activity injected at time tinj, and λ is the decay constant for the injected radioisotope. AC(tsc) is determined from the spatial density of counts acquired from the VOI. Tumor uptake was measured in terms of maximum voxel standardized uptake value, SUVmax. Response assessment adhered to Positron Emission Tomography (PET) Response Criteria in Solid Tumors (PERCIST 1.0).

Relationship between patient best response to T-DM1 and measured tumor uptake of 64Cu-DOTA-trastuzumab employed a t-test with a 0.05 two-sided significance level comparing minimum uptake in responsive vs non-responsive patients. Tumor uptake measured as SUV defined as SUV = AC(tsc) Wb /\[Dinj exp(-λ(tsc - tinj)\] , where AC(tsc) is the activity concentration in the volume of interest (VOI, e. g., a tumor), Wb is the patient's body weight, Dinj is the activity injected at time tinj, and λ is the decay constant for the injected radioisotope. AC(tsc) is determined from the spatial density of counts acquired from the VOI. Tumor uptake was measured in terms of minimum voxel standardized uptake value, SUVmin. Response assessment adhered to Positron Emission Tomography (PET) Response Criteria in Solid Tumors (PERCIST 1.0).

Patients undergo whole body fludeoxyglucose F 18 PET/CT. Patients then receive trastuzumab IV (45 mg) over 15 minutes immediately before receiving copper Cu 64-DOTA-trastuzumab IV (\<15 mCi; protein dose 5 mg) and then undergo PET scans at 24 and 48 hours. Patients then receive ado-trastuzumab emtansine IV (3.6 mg/kg) every 3 weeks until complete response or disease progression at the discretion of the treating oncologist. Patients undergo restaging by whole body fludeoxyglucose F 18 PET/CT every 6 weeks after initiation of treatment until disease progression.

fludeoxyglucose F 18: Undergo fludeoxyglucose F 18 PET/CT

positron emission tomography: Undergo fludeoxyglucose F 18 PET/CT

computed tomography: Undergo fludeoxyglucose F 18 PET/CT

trastuzumab: Given IV

copper Cu 64-DOTA-trastuzumab: Given IV

positron emission tomography: Undergo copper Cu-DOTA-trastuzumab PET

ado-trastuzumab emtansine: Given IV

laboratory biomarker analysis: Correlative studies

Diagnostic (Copper Cu 64-DOTA-trastuzumab PET)

Relationship Between Average Tumor Uptake of Copper Cu 64-DOTA-trastuzumab as Measured by PET and Patient Best Response

Relationship Between Tumor Minimum Uptake of Copper Cu 64-DOTA-trastuzumab as Measured by PET and Patient Best Response

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Intralesional Treatment With Interleukin-2 (Proleukin) in Soft Tissue Melanoma Metastases	NCT00204581	Melanoma	Interleukin-2 (...	18 Years -	University Hospital Tuebingen
Sipuleucel-T With or Without Radiation Therapy in Treating Patients With Hormone-Resistant Metastatic Prostate Cancer	NCT01807065	Adenocarcinoma ... Bone Metastases Hormone-resista... Recurrent Prost... Soft Tissue Met... Stage IV Prosta...	sipuleucel-T external beam r... laboratory biom...	18 Years -	City of Hope Medical Center
Copper Cu 64-DOTA-Trastuzumab PET in Predicting Response to Treatment With Ado-Trastuzumab Emtansine in Patients With Metastatic HER2 Positive Breast Cancer	NCT02226276	Bone Metastases HER2-positive B... Liver Metastase... Lung Metastases Recurrent Breas... Soft Tissue Met... Stage IV Breast...	fludeoxyglucose... positron emissi... computed tomogr... trastuzumab copper Cu 64-DO... positron emissi... ado-trastuzumab... laboratory biom...	18 Years -	City of Hope Medical Center
Intralesional Treatment With Interleukin-2 (Proleukin) in Soft Tissue Melanoma Metastases	NCT00204581	Melanoma	Interleukin-2 (...	18 Years -	University Hospital Tuebingen

Spots Global Cancer Trial Database for soft tissue metastases